A Phase 4 interventional study of Balanced Gelatin Solution and Acetate Ringer's Solution in Sepsis and Intra-Abdominal Infections, sponsored by Shanghai Zhongshan Hospital. Recruiting at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Treatment
The goal of this randomized clinical trial is to evaluate whether balanced gelatin solution is more effective and safe than balanced crystalloid solution for perioperative fluid management in adults with sepsis undergoing emergency abdominal surgery. Sepsis often causes severe fluid loss from the bloodstream into tissues, leading to low blood pressure, impaired organ function, and the need for urgent fluid resuscitation. Balanced gelatin, a colloid solution, may help maintain intravascular volume more effectively than crystalloid alone.
In this study, participants are randomly assigned in a 1:1 ratio to receive either balanced gelatin or Ringer's acetate during surgery and in the first 24 hours afterward. All patients receive standardized anesthesia care, goal-directed fluid therapy, and protocolized use of vasoactive drugs. The main questions the study aims to answer are:
Participants will be followed throughout hospitalization and contacted again on postoperative day 28 and day 90 to assess survival, complications, and health-related quality of life. The trial is double-blind, meaning that patients, clinicians, and outcome assessors do not know which fluid is being used. An independent Data and Safety Monitoring Board will oversee patient safety during the study.
The findings of this trial are expected to provide important evidence to guide perioperative fluid resuscitation strategies for septic patients undergoing emergency surgery.
Study Background Sepsis is a life-threatening syndrome caused by a dysregulated host response to severe infection, which can rapidly progress to septic shock, multiple organ dysfunction, and death.Despite advances in recognition and treatment in recent years, sepsis remains a major global health challenge, with overall mortality rates still ranging from 18% to 30%.Pathophysiologically, sepsis is characterized by increased capillary permeability and vasodilation, resulting in substantial fluid extravasation into the interstitial space, tissue edema, and intravascular volume depletion. These changes lead to inadequate tissue perfusion, impaired oxygen delivery, and ultimately organ dysfunction. Therefore, timely and appropriate fluid resuscitation remains one of the most fundamental and essential components of sepsis management. Individualized, goal-directed fluid therapy aims to improve systemic perfusion while minimizing the risks associated with fluid overload.
In 2001, Rivers et al. introduced the concept of early goal-directed therapy (EGDT), demonstrating significant mortality reduction (30.5% vs 45%) in patients with severe sepsis and septic shock.This finding prompted widespread adoption of early aggressive fluid resuscitation. However, three large multicenter trials published between 2014 and 2015 (ARISE, ProCESS, and ProMISe) later found no significant mortality differences between EGDT and usual care (approximately 18-25%).These results suggested that with improvements in routine clinical practice, contemporary usual care may already include adequate hemodynamic optimization.
Based on this evidence, the 2016 Surviving Sepsis Campaign (SSC) guidelines recommended administration of at least 30 mL/kg of crystalloid fluid within the first 3 hours for patients with sepsis-induced hypoperfusion, followed by hemodynamic-guided adjustment.Because many participants in these large trials had already received similar volumes before randomization, this dosage became associated with favorable outcomes. The 2021 SSC guideline retained this recommendation, though downgraded from a "strong" to a "weak" recommendation in the absence of new high-quality evidence.This highlights persistent uncertainty and the need for further research on optimal fluid type and strategy in sepsis resuscitation.
Increasing attention has been paid to microcirculation in recent years. While macrocirculatory parameters such as blood pressure may normalize after resuscitation, this does not necessarily indicate restoration of tissue-level perfusion.Persistent microcirculatory dysfunction may contribute to inadequate oxygen delivery and delayed organ recovery. Understanding how different fluid therapies influence both macro- and microcirculation is therefore crucial for optimizing outcomes.
Currently used resuscitation fluids include crystalloids and colloids. Crystalloids rapidly redistribute into the interstitial space and may exacerbate tissue edema-particularly in sepsis where capillary permeability is increased-potentially impairing microcirculatory flow.Colloids contain larger molecules that remain intravascular for longer periods, generating oncotic pressure and maintaining circulating volume more effectively, which may theoretically support microcirculatory perfusion and oxygen delivery. Clinically used colloids include albumin, hydroxyethyl starch (HES), and gelatin. Albumin is effective but costly and limited in availability. HES has fallen out of favor due to its association with kidney injury and increased mortality in sepsis.Gelatin, derived from bovine collagen hydrolysates, is now the only artificial colloid still recommended by guidelines for hypovolemia in sepsis patients.Nevertheless, high-quality randomized controlled evidence comparing gelatin with crystalloids in sepsis remains insufficient.
Based on this background, the present study focuses on balanced gelatin solution-a compound solution containing 4% succinylated gelatin in a balanced crystalloid carrier. We hypothesize that, compared with balanced crystalloid alone, balanced gelatin may better support hemodynamic stability through its colloid osmotic effect, more effectively correct fluid imbalance, improve microcirculatory perfusion, promote organ function recovery, and ultimately improve clinical outcomes. This randomized controlled trial is designed to rigorously test this hypothesis.
Patient and Public Involvement (PPIE)
During the protocol development stage, this study incorporated Patient and Public Involvement (PPIE). Three public contributors without medical backgrounds were invited to review the full protocol and informed consent form prior to study initiation. They provided feedback from the perspective of typical patients and family members. The main areas of concern included:
Based on this feedback, the research team has revised and optimized the protocol background, the explanation of "double-blind" in the informed consent form, the safety management procedures, the follow-up plan, and the approach for disseminating study results. These adjustments aim to enhance the clarity, acceptability, and overall engagement of patient participants.
Study Objectives Primary Objective To evaluate the effectiveness of balanced gelatin solution in perioperative fluid management for septic patients undergoing emergency non-cardiac surgery, with emphasis on:reducing perioperative positive fluid balance；promoting hemodynamic stability；improving microcirculatory perfusion；and supporting organ function recovery and clinical outcomes.
Secondary Objective To assess the safety of balanced gelatin solution in this population, focusing on its effects on kidney function, coagulation status, and common postoperative complications.
Study Design This is a prospective, multicenter, randomized, double-blind, controlled clinical trial with an adaptive design incorporating sample size re-estimation. An initial sample size of 318 patients (159 per group) will be recruited, with an interim analysis after enrollment of 50% of participants to reassess the required sample size. Patients are randomized in a 1:1 ratio to receive either balanced gelatin or crystalloid solution (Ringer's acetate). Randomization is stratified by baseline blood lactate level (≤ 4 mmol/L vs > 4 mmol/L) using a central dynamic allocation system to ensure balance between groups.
Population Eligible patients are adults (≥18 years) with sepsis (per Sepsis-3 criteria) due to abdominal infection requiring emergency surgery. Inclusion requires a SOFA score ≥2 and lactate >2 mmol/L. Key exclusions include prior colloid use within 24 hours, expected death within 48 hours, advanced heart failure, severe ARDS, pre-existing renal replacement therapy, severe coagulopathy, liver failure, or allergy to gelatin.
Interventions All participants receive standardized anesthesia care. Intraoperative fluid therapy follows a goal-directed fluid therapy (GDFT) protocol guided by stroke volume (SV) monitoring. To ensure double-blinding, the study fluid (either balanced gelatin or Ringer's acetate) is prepared by independent, unblinded personnel, remaining masked to clinicians, investigators, and patients. During anesthesia, all patients receive a baseline infusion of Ringer's acetate at 3 mL/kg/h (ideal body weight, IBW). For volume expansion, fluid boluses (3 mL/kg IBW of the assigned study fluid over 5 minutes) are administered; a bolus is repeated if SV increases by >10%. Postoperatively, the assigned study fluid remains the primary resuscitation fluid for up to 24 hours. The cumulative dose of the study fluid is capped at 30 mL/kg (IBW) within this 24-hour intervention period; if the limit is reached, subsequent resuscitation reverts to Ringer's acetate. Vasoactive or inotropic support is standardized based on predefined hemodynamic triggers after optimizing SV.
Endpoints
Primary endpoints include:
Cumulative fluid balance within 24 hours after surgery. Proportion of patients achieving hemodynamic stability within 24 hours. Secondary endpoints include kidney function, SOFA score dynamics, lactate clearance, need for vasopressors or renal replacement therapy, postoperative complications, ICU and hospital length of stay, and all-cause mortality at 28 and 90 days. Safety endpoints include pulmonary edema, arrhythmias, and acute kidney injury.
Follow-up Patients will be followed during hospitalization and by structured telephone interviews at day 28 and day 90. Follow-up assessments include survival, complications, and health-related quality of life using the EQ-5D-5L questionnaire.
Blinding and Oversight The study is double-blind: patients, treating clinicians, outcome assessors, and statisticians remain unaware of group allocation. Randomization and drug packaging are handled by independent, unblinded coordinators under the supervision of independent witnesses to ensure masking integrity. Strict role isolation is maintained, ensuring that any personnel with access to allocation information are prohibited from participating in subject recruitment, clinical intervention, follow-up, or data analysis. Emergency unblinding is permitted only for patient safety. An independent Data and Safety Monitoring Board (DSMB) will oversee trial conduct, perform interim analyses for the adaptive design, and review adverse events.
Statistical Note:
A fixed-sequence hierarchical testing procedure will be applied to the primary endpoints to maintain the overall family-wise type I error rate at 0.05. Primary endpoint 1 (24-hour cumulative fluid balance) will be tested first; primary endpoint 2 (hemodynamic stability) will only be formally tested for statistical significance if the first endpoint reaches p \< 0.05.
Significance By directly comparing balanced gelatin with crystalloids in septic patients undergoing emergency abdominal surgery, this trial will provide critical evidence regarding the efficacy and safety of gelatin-based fluid resuscitation. Results are expected to inform perioperative fluid management strategies and contribute to guideline development in the management of sepsis.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 318 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to the balanced gelatin group receive balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier) for volume expansion during the surgical procedure, guided by a stroke volume (SV) monitoring protocol. The study fluid management may continue for up to 24 hours post-randomization according to clinical needs. The cumulative dose of balanced gelatin is capped at 30 mL/kg (ideal body weight) within the first 24 hours; once reached or when the study fluid is unavailable, Ringer's acetate is used for subsequent resuscitation.
Drug: Balanced Gelatin Solution
Patients randomized to the crystalloid group receive acetate Ringer's solution as the sole resuscitation fluid during emergency abdominal surgery for sepsis, according to the same goal-directed protocol guided by stroke volume monitoring. No gelatin solution or lactate-containing crystalloids will be administered within the first 24 hours post-randomization. The total volume of crystalloid infusion is not limited.
Drug: Acetate Ringer's Solution
Description: Balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier). Administered as the primary resuscitation fluid during the intraoperative period and may be continued into the first 24 postoperative hours if clinically indicated and available. Infusion follows a stroke volume-guided, goal-directed fluid therapy protocol. The total dose of the study fluid is capped at 30 mL/kg (ideal body weight) within 24 hours. If the maximum dose is reached or the study fluid is no longer available postoperatively, additional resuscitation is provided with Ringer's acetate solution.
Also known as: Succinylated Gelatin 4%, Gelatin Infusion, Gelaspan
Description: Acetate Ringer's solution, a balanced crystalloid, administered as the sole resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Fluid therapy follows the same stroke volume-guided, goal-directed protocol as the experimental arm. This regimen is maintained throughout the intraoperative period and the first 24 postoperative hours to ensure the exclusion of any exogenous colloids or lactate-containing solutions. There is no upper limit for the total volume of crystalloid infusion.
Also known as: Balanced Crystalloid Solution, Ringer's Acetate
Primary Outcome 1: Net fluid balance within 24 hours after surgery
\[Hierarchical Testing Sequence: 1st\] This is the first primary endpoint in the hierarchical testing sequence. Net fluid balance is defined as the difference between total infused volume and total output volume during surgery and the first 24 postoperative hours. Input volume includes all study fluids (balanced gelatin solution or acetate Ringer's), albumin, blood products, and maintenance crystalloid infusion. Excluded are solvent volumes \<50 mL and non-therapeutic fluids such as irrigation or enteral/oral intake. Albumin is recorded in mL of solution administered. Blood product volumes are standardized: packed red blood cells 1 unit = 200 mL; plasma = actual volume; apheresis platelets 1 therapeutic dose = 250 mL; cryoprecipitate 1 unit = 25 mL (with center-specific adjustment allowed). Output volume includes intraoperative blood loss, urine output, and measurable drainage (thoracic, abdominal, nasogastric, etc.), excluding insensible or unmeasurable losses.
Time frame: Intraoperative period and postoperative 24 hours
Primary Outcome 2: Proportion of patients achieving hemodynamic stability within 24 hours after surgery
\[Hierarchical Testing Sequence: 2nd\] This is the second primary endpoint in the hierarchical testing sequence. Hemodynamic stability (HDS) is defined as meeting all of the following three criteria at postoperative 24 hours: 1. Mean arterial pressure (MAP) ≥65 mmHg without vasopressor support, sustained ≥1 hour after discontinuation of vasopressors, with all subsequent MAP measurements ≥65 mmHg. 2. Blood lactate ≤2 mmol/L, based on the most recent venous or arterial sample. 3. Urine output ≥1 mL/kg/h, based on the average over the preceding 6 hours. The outcome measure is the percentage of patients in each group who fulfill all three criteria.
Time frame: Postoperative 24 hours
Secondary Outcome 1.1: Intensity of study drug use within 24 hours after surgery
Cumulative volume of study drug administered from randomization to 24 hours postoperatively, standardized by ideal body weight (mL/kg).
Time frame: Randomization to postoperative 24 hours
Secondary Outcome 1.2: Blood product utilization rate within 24 hours after surgery
Proportion of patients receiving any blood product during the intervention period, regardless of type. Each patient is counted once even if multiple blood products are used.
Time frame: Randomization to postoperative 24 hours
Secondary Outcome 1.3: Vasopressor load within 24 hours after surgery
Vasopressor dose converted to norepinephrine-equivalent according to predefined equivalence table (norepinephrine:epinephrine:dopamine:phenylephrine:vasopressin = 1:1:0.01:0.01:0.02), normalized by ideal body weight and infusion time (μg/kg/min).
Time frame: Randomization to postoperative 24 hours
Secondary Outcome 1.4: Proportion of patients receiving inotropic drugs within 24 hours after surgery
Proportion of patients treated with any inotrope (dobutamine, milrinone, levosimendan, etc.) within 24 hours postoperatively.
Time frame: Randomization to postoperative 24 hours
Secondary Outcome 2.1: Intraoperative lactate reduction magnitude
Difference between baseline lactate and lactate at end of surgery (mmol/L).
Time frame: Baseline to end of surgery
Secondary Outcome 2.2: 24-hour lactate reduction magnitude
Difference between baseline lactate and lactate at 24 hours after surgery (mmol/L).
Time frame: Baseline to postoperative 24 hours
Secondary Outcome 2.3: Normalization rate of capillary refill time (CRT) at end of surgery
Proportion of patients with CRT ≤3 seconds at end of surgery, measured every 30 minutes from preoperative period to end of surgery using standardized glass-slide method.
Time frame: From baseline to end of surgery
Secondary Outcome 3.1: Proportion of patients with decrease in SOFA score at postoperative day 3 compared with baseline
SOFA (Sequential Organ Failure Assessment) score is used to evaluate dysfunction across six organ systems (respiratory, coagulation, hepatic, cardiovascular, renal, and central nervous system), with each system scored from 0 to 4 and a total score ranging from 0 to 24. In this study, SOFA scoring follows the updated SOFA-2 criteria, including standardized rules for handling sedation, intubation, and mortality. Improvement is defined as a decrease in the total SOFA score at postoperative day 3 compared with baseline (score difference \> 0). If the SOFA score does not decrease or increases (difference ≤ 0), the patient is categorized as not improved.
Time frame: Baseline (preoperative) to postoperative day 3
Secondary Outcome 3.2: Proportion of patients with severe organ dysfunction within 3 days after surgery
Severe organ dysfunction is defined as SOFA score ≥3 in any organ system (respiratory, coagulation, liver, cardiovascular, renal, CNS) at least once during POD1-3. Deaths are counted as maximum scores.
Time frame: Postoperative day 1 to day 3
Secondary Outcome 3.3: Incidence of acute kidney injury within 3 days after surgery
Acute kidney injury (AKI) is defined according to KDIGO 2012 criteria, assessed at POD1, POD2, and POD3.
Time frame: Baseline to postoperative day 3
Secondary Outcome 3.4: Cumulative duration of renal replacement therapy within 28 days after surgery
Total number of days on renal replacement therapy (CRRT, intermittent hemodialysis, or peritoneal dialysis) during the 28 days after surgery.
Time frame: Postoperative day 1 to day 28
Secondary Outcome 3.5: Incidence of coagulopathy within 3 days after surgery
Coagulopathy is defined as PT prolongation \>3 seconds from baseline or INR \>1.5 at any time during POD1-3.
Time frame: Baseline to postoperative day 3
Secondary Outcome 3.6: Duration of ventilator-free time within 24 hours after surgery
Total hours without invasive or non-invasive mechanical ventilation in the first 24 hours postoperatively. Interruptions \<1 hour are excluded.
Time frame: Postoperative 24 hours
Secondary Outcome 3.7: Duration of ventilator-free time within 7 days after surgery
Total days without invasive or non-invasive mechanical ventilation during the first 7 postoperative days. Interruptions \<1 day are excluded.
Time frame: Postoperative day 1 to day 7
Secondary Outcome 3.8: Duration of vasopressor-free time within 24 hours after surgery
Total hours during which MAP ≥65 mmHg is maintained without vasopressor support, sustained ≥1 hour, within the first 24 hours.
Time frame: Postoperative 24 hours
Secondary Outcome 3.9: Duration of vasopressor-free time within 72 hours after surgery
Total hours during which MAP ≥65 mmHg is maintained without vasopressor support, sustained ≥1 hour, within the first 72 hours.
Time frame: Postoperative day 1 to day 3
Secondary Outcome 4.1: Length of ICU stay
Number of calendar days spent in the intensive care unit after surgery.
Time frame: From ICU admission to ICU discharge
Secondary Outcome 4.2: Length of total hospital stay
Number of calendar days from hospital admission to hospital discharge.
Time frame: From hospital admission to discharge
Secondary Outcome 5.1: All-cause mortality within 28 days after surgery
Death from any cause within 28 days postoperatively.
Time frame: Postoperative day 1 to day 28
Secondary Outcome 5.2: All-cause mortality within 90 days after surgery
Death from any cause within 90 days postoperatively.
Time frame: Postoperative day 1 to day 90
Safety Outcome 1.1: Incidence of postoperative respiratory complications (ARDS)
ARDS defined as PaO₂/FiO₂ ratio \<200 at any arterial blood gas measurement within 7 days postoperatively. Patients without postoperative blood gas data are excluded. Deaths without ARDS evidence are counted as negative.
Time frame: Postoperative day 1 to day 7
Safety Outcome 1.2: Incidence of postoperative cardiovascular complications (arrhythmias)
New-onset arrhythmias within 28 days postoperatively, including supraventricular tachycardia, ventricular tachycardia, or atrial fibrillation/flutter. Multiple events in same patient count once.
Time frame: Postoperative day 1 to day 28
Safety Outcome 1.3: Incidence of postoperative renal complications
Defined as new renal dysfunction (serum creatinine ≥2× baseline) or need for renal replacement therapy (RRT) within 28 days after surgery. One patient counts once regardless of multiple events.
Time frame: Postoperative day 1 to day 28
Safety Outcome 2.1: Health-related quality of life at postoperative day 90
Health-related quality of life will be assessed at postoperative day 90 using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The descriptive system covers five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on 5 levels (1 = no problems, 5 = extreme problems). Responses are converted to a health state code (e.g., 21321), which is then mapped to a utility index score using the Chinese EQ-5D-5L value set (range: -0.391 to 1.000, where 1.000 = full health and values \<0 represent states worse than death). In addition, participants will provide a self-rated health score on the EQ-VAS, a vertical visual analog scale ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: Postoperative day 90
Exploratory Outcome 1.1: Minimum and maximum plasma osmolality during surgery
Plasma osmolality measured hourly from start of surgery (Tpre) to end of surgery (T0). Minimum and maximum values recorded.
Time frame: Intraoperative period (Tpre to T0)
Exploratory Outcome 1.2: Minimum pH value during surgery
Arterial blood gas pH measured hourly from Tpre to T0. Lowest recorded value used.
Time frame: Intraoperative period (Tpre to T0)
Exploratory Outcome 1.3: Central venous oxygen saturation (ScvO₂) before and after surgery
ScvO₂ measured at Tpre and T0.
Time frame: Preoperative (Tpre) and end of surgery (T0)
Exploratory Outcome 1.4: Central venous-to-arterial CO₂ gap (P(cv-a)CO₂) before and after surgery
P(cv-a)CO₂ measured at Tpre and T0.
Time frame: Preoperative (Tpre) and end of surgery (T0)
Exploratory Outcome 2.1: Sublingual microvascular flow index (MFI)
Semi-quantitative assessment of microvascular flow using SDF or IDF imaging system, measured at Tpre and T0.
Time frame: Preoperative (Tpre) and end of surgery (T0)
Exploratory Outcome 2.2: Perfused boundary region (PBR)
Glycocalyx integrity marker, assessed by SDF or IDF imaging system, measured at Tpre and T0. Higher values indicate more severe damage.
Time frame: Preoperative (Tpre) and end of surgery (T0)
Exploratory Outcome 2.3: Red blood cell flow velocity
Quantitative assessment of RBC centerline velocity (μm/s) using particle tracking algorithm, measured at Tpre and T0.
Time frame: Preoperative (Tpre) and end of surgery (T0)
Exploratory Outcome 3.1: Circulating biomarkers of early renal injury (NGAL, Cystatin C)
Plasma neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C concentrations will be measured to evaluate early renal injury.
Time frame: Preoperative (before anesthesia induction), end of surgery, postoperative day 1, postoperative day 2, and postoperative day 3
Exploratory Outcome 3.2: Circulating biomarkers of coagulopathy (TAT, PAI-1)
Plasma thrombin-antithrombin complex (TAT) and plasminogen activator inhibitor-1 (PAI-1) concentrations will be measured to assess coagulation function.
Time frame: Preoperative (before anesthesia induction), end of surgery, postoperative day 1, postoperative day 2, and postoperative day 3
Exploratory Outcome 3.3: Circulating cardiac biomarker (NT-proBNP)
Plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration will be measured to assess cardiac stress.
Time frame: Preoperative (before anesthesia induction), end of surgery, postoperative day 1, postoperative day 2, and postoperative day 3
Exploratory Outcome 3.4: Circulating inflammatory and immune biomarkers
Plasma concentrations of procalcitonin (PCT), C-reactive protein (CRP/hs-CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), and monocyte HLA-DR expression will be measured to evaluate systemic inflammation and immune response.
Time frame: Preoperative (before anesthesia induction), end of surgery, postoperative day 1, postoperative day 2, and postoperative day 3
Exploratory Outcome 3.5: Circulating endothelial biomarkers (Syndecan-1, Ang-2)
Plasma syndecan-1 and angiopoietin-2 concentrations will be measured to assess endothelial integrity and glycocalyx damage.
Time frame: Preoperative (before anesthesia induction), end of surgery, postoperative day 1, postoperative day 2, and postoperative day 3
Exploratory Outcome 4.1: Incidence of postoperative gastrointestinal intolerance (POGI)
Postoperative gastrointestinal intolerance is defined as an i-Feed score of 3-5 at postoperative day 1, day 3, or day 7, without ever reaching ≥6. Each patient will be counted once.
Time frame: Postoperative day 1, postoperative day 3, and postoperative day 7
Exploratory Outcome 4.2: Incidence of postoperative gastrointestinal dysfunction (POGD)
Postoperative gastrointestinal dysfunction is defined as an i-Feed score ≥6 at postoperative day 1, day 3, or day 7. Each patient will be counted once.
Time frame: Postoperative day 1, postoperative day 3, and postoperative day 7
Plan to share: Undecided — At this time, the study team has not finalized an IPD sharing plan. This is a multicenter trial in critically ill patients; data governance, site ownership, and de-identification procedures are still under review. If sharing is pursued, it would be limited to a de-identified dataset sufficient to reproduce key findings-not the complete raw source data (e.g., free-text notes or imaging). Any decision will be guided by participant privacy, consent language, local/national regulations, and approvals by the sponsor/IRB/DSMB. Aggregate results will be reported in publications and on ClinicalTrials.gov.
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