An interventional study of Enteral fluid and Intravenous fluid in Critical Illness, Surgery and Enteral Feeding Intolerance, sponsored by Medical University of Lublin. Not yet recruiting at 5 sites in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Medical University of Lublin · Not applicable, Interventional, and Prevention
Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial.
Each patient will be fed via the gastrointestinal tract. Half of the patients will receive enteral nutrition (EN) with additional fluids, and the rest will receive undiluted EN.
The primary aim of this study is feeding intolerance assessment in both groups of patients.
Approximately 50 % of the intensive care unit (ICU) population has feeding intolerance (FI), which includes nausea, vomiting, diarrhea, and others. Some studies suggest that FI can be alleviated in patients fed with supplemental parenteral nutrition (PN).
Adult patients after elective major abdominal surgeries who are planned to be admitted to the ICU can be included in the trial.
After the ICU admission, the patient will be stabilized, including warming, correction of water, electrolyte, and acid-base disorders, and blood transfusion if required. The fluid therapy will be monitored using the transpulmonary dilution technique.
Then, an attending physician will contact an investigator. The investigator will decide about the randomization (no contraindication). The investigators plan to maintain fluid therapy with continuous Glucose-Na-K Baxter 50 mg/ml solution for infusion (GNAK). GNAK will be administered in the same flow as EN, enterally or intravenously (i.v.).
Patients will be randomized to one of two studied groups:
The attending physician will correct all fluid disturbances with balanced fluids or blood products according to laboratory tests and hemodynamic monitoring. GNAK will only be given as maintenance fluid with EN.
The primary outcome of our study will be feeding intolerance (FI).
FI is a composite outcome consisting of at least one of the following:
Secondary outcomes (routinely performed procedures):
Follow-up:
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Medical University of Lublin is the lead sponsor of 62 studies on the registry; 11 are open to participants now.
Compared within Critical Illness, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Enteral nutrition will be given continuously with glucose-Na-K Baxter 50 mg/ml solution for infusion (GNAK)-both products to the gastrointestinal tract in the same volume.
Other: Enteral fluid
Enteral nutrition will be given continuously to the gastrointestinal tract. GNAK will be given continuously intravenously in the same volume.
Other: Intravenous fluid
GNAK will be administered to the gastrointestinal tract with EN in the same volume.
Also known as: ENF
Undiluted EN will be given to the gastrointestinal tract. GNAK, in the same volume, will be administered intravenously.
Also known as: IVF
Number of participants having nausea and vomiting
Incidents of nausea and vomiting (nausea measured with a 4-point verbal descriptive scale (0=no nausea, 1=mild, 2=moderate, 3=severe))
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Number of participants having diarrhea
Incidents of diarrhea (≥ three loose stools per day)
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Number of participants having increased gastric residual volume
Increased gastric residual volume (\> 500 ml of gastric aspirate/ 6 hours). Only in patients after lower GI tract surgeries (with intact stomach and gastric feeding)
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Number of participants in whom target EN will not be achieved
Achieving target EN on day three and later: 80% of protein requirements according to ESPEN (1.3/kg of ideal body weight (patients BMI \< 30) or adjusted body weight, BMI ≥ 30)
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Number of participants in whom prokinetic agents will be used
Administration of prokinetic agents according to the intensivist discretion. Starting with both erythromycin (125 mg twice daily enterally) and metoclopramide (10mg three times per day i.v.)
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Days of support with PN
Days of support with parenteral nutrition during the ICU stay.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Contribution of PN in total nutrition
Percentage contribution of parenteral nutrition in total patient feeding understand as protein demands
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Insulin consumption
Insulin consumption - units per day and total per stay
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Electrolyte supplementation
Electrolyte supplementation - potassium, phosphorus, calcium, and magnesium in mmol/ stay
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Enteral access obstruction
Need for replacement outside the ICU or under endoscopy assistance. Number of such procedures per stay.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Intraabdominal pressure
Intraabdominal pressure via urinary catheter twice daily
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Sequential Organ Failure Assessment Score (SOFA)
Calculating SOFA twice daily - from 0 to 24 - 0 means the lack of organ failure; 24 multiorgan failure
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Fluid balance
Additional crystalloids or colloids given intravenously during ICU stay measured in milliliters
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Blood products transfusion
Transfusion of any blood products, including red-packed cells, fresh-frozen plasma, platelets, and cryoprecipitate, measured in units per stay.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Acute kidney injury (AKI)
Recognition of AKI according to Kidney Disease: Improving Global Outcomes (KDIGO) definition
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Vasoactive drugs
Usage of vasoactive drugs including noradrenaline, dobutamine, dopamine, adrenaline, and others measured in milligrams as cumulative dose per stay
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Stroke volume variation
Measurement of stroke volume variation presented in percent twice daily during the patient stay
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Cardiac output
Measurement of cardiac output (L/min) with pulmonary thermodilution technique twice daily during the patient's stay
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Systemic vascular resistance
Measurement of systemic vascular resistance (dynes/sec/cm-5) with pulmonary thermodilution technique twice daily during the patient's stay
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Extravascular lung water
Measurement of extravascular lung water index (ml/kg) with pulmonary thermodilution technique twice daily during the patient's stay
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Lactates
At least once daily, arterial blood lactates (mmol/L) will be measured
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Complete blood count (CBC)
Once daily CBC will be tested
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Blood proteins
Plasma protein concentrations (g/dL) will measured at least once a week.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Infection site
Site of infection during the ICU stay.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Antibiotics
Antibiotics wchich will be used in ICU.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Blood albumins
Plasma albumin concentrations (g/dL) will measured at least once a week.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
C-reactive protein (CRP)
CRP (mg/L) will be measured once daily.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Procalcitonin (PCT)
PCT (ng/mL) will be measured once daily.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Mechanical ventilation
Mechanical ventilation time in hours per stay
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Intensive care unit (ICU) stay
ICU stay in days
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Hospital stay
Hospital stay in days
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Hospital mortality
In-hospital mortality
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Intestinal fatty-acid binding protein (I-FABP)
I-FABP concentrations (nmol/mL) will be measured in the blood and urine once daily.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Zonulin
Zonulin concetration (ng/mL) will measured in the patient's blood on the 1st day, 4th day, and at the ICU discharge.
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Ketones
Serum ketone concentrations (mmol/L) will be collected and measured at ICU admission, 4th day, and discharge
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Microbiome
Intestinal microbiome collection upon admission and discharge from the ICU. Sequencing of the V3 V4 region of the 16SrRNA gene using NGS using Illumina technology, 2x250 bp, min. 100,000 readings, including DNA isolation. Preparation of the OTU table and basic alpha biodiversity measures
Time frame: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Quality of recovery
Phone interview using a modified version of Quality of recovery-40 scale (37-185 points,more points better) 30 days after randomization
Time frame: 30 days after randomization
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Jan 2027, 24 months later.
Of 399 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 24 months is above that.
Counting every sponsor, half of 403 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Medical University of Lublin