An interventional study of Peripheral Perfusion Index-guided Fluid Resuscitation Protocol and Conventional Goal-Directed Fluid Resuscitation in Sepsis, Septic Shock and Acute Skin Failure, sponsored by Ying Wang. Recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Ying Wang · Not applicable, Interventional, and Treatment
This prospective, randomized, controlled trial aimed to evaluate whether fluid resuscitation guided by the Peripheral Perfusion Index (PPI) could reduce the incidence of Acute Skin Failure (ASF) in elderly critically ill patients. A total of 216 patients aged ≥65 years with sepsis or other types of shock requiring early aggressive fluid resuscitation were enrolled and randomly assigned in a 1:1 ratio to either the PPI-guided resuscitation group or the conventional resuscitation group. The intervention group targeted maintaining PPI ≥1.4 in addition to conventional hemodynamic goals, while the control group followed standard resuscitation protocols. The primary outcome was the incidence of ASF within 7 days of ICU admission, diagnosed according to NPUAP/EPUAP (2014) criteria. Secondary outcomes included time to ASF occurrence, lactate clearance, cumulative fluid balance, organ function, and long-term prognosis.
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This study's planned enrollment of 216 is above the median of 105 across 896 interventional studies indexed under Sepsis.
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Exclusion Criteria:
Other: Peripheral Perfusion Index-guided Fluid Resuscitation Protocol
Other: Conventional Goal-Directed Fluid Resuscitation
In addition to achieving conventional macro-hemodynamic goals (mean arterial pressure ≥65 mmHg, etc.), a resuscitation protocol targeting a Peripheral Perfusion Index (PPI) value ≥1.4 is implemented. PPI is continuously monitored via a finger pulse oximeter. If PPI remains below 1.4 for \>30 minutes, a fluid responsiveness assessment (e.g., passive leg raising test) is performed. Fluid boluses (balanced crystalloid) are administered only if the patient is fluid-responsive. Otherwise, vasoactive agents are optimized.
Fluid resuscitation is performed according to the Surviving Sepsis Campaign International Guidelines. Resuscitation targets include: mean arterial pressure ≥65 mmHg, central venous pressure 8-12 mmHg, urine output ≥0.5 mL·kg-¹·h-¹, and normalization/decreasing trend of serum lactate. The type, rate, and volume of fluid administration are determined by the treating physician based on these standard macro-hemodynamic and perfusion parameters.
Incidence of Acute Skin Failure（per the NPUAP/EPUAP 2014 Guidelines）
Proportion of patients who develop new-onset Acute Skin Failure (ASF) within 7 days after ICU admission. ASF is diagnosed and staged according to the NPUAP/EPUAP (2014) criteria.
Time frame: From ICU admission up to 7 days
Time to Acute Skin Failure (ASF) Onset
Number of days from ICU admission to the first diagnosis of ASF (assessed in patients who develop ASF)
Time frame: From ICU admission up to 7 days
Maximum Stage of Acute Skin Failure
The most severe stage of ASF (according to NPUAP/EPUAP 2014 criteria) observed within 7 days after ICU admission
Time frame: From ICU admission up to 7 days
Lactate Clearance Rate at 6 Hours
Percentage decrease in serum lactate concentration from baseline to 6 hours after initiation of resuscitation
Time frame: Baseline and 6 hours after resuscitation initiation
Lactate Clearance Rate at 24 Hours
Percentage decrease in serum lactate concentration from baseline to 24 hours after initiation of resuscitation
Time frame: Baseline and 24 hours after resuscitation initiation
Cumulative Fluid Balance at 72 Hours
Net fluid balance (total fluid intake minus total output) calculated over the first 72 hours of ICU stay
Time frame: From ICU admission up to 72 hours
Incidence of Acute Kidney Injury
Proportion of patients who develop AKI according to KDIGO criteria within 7 days after ICU admission
Time frame: From ICU admission up to 7 days
Duration of Mechanical Ventilation
Total number of days requiring invasive mechanical ventilation during ICU stay
Time frame: From ICU admission until ICU discharge, up to 90 days
Length of ICU Stay
Total number of days from ICU admission to ICU discharge
Time frame: From ICU admission until ICU discharge, up to 90 days
28-Day All-Cause Mortality
Proportion of patients who die from any cause within 28 days after ICU admission
Time frame: From ICU admission up to 28 days
90-Day All-Cause Mortality
Proportion of patients who die from any cause within 90 days after ICU admission
Time frame: From ICU admission up to 90 days
Barthel Index at Hospital Discharge
Score of the Barthel Index (a measure of activities of daily living) assessed at the time of hospital discharge in surviving patients. Range: 0-100, higher scores indicate greater independence
Time frame: At hospital discharge, up to 90 days after ICU admission
Total Hospitalization Costs
Total direct medical costs incurred during the index hospitalization, expressed in local currency
Time frame: From hospital admission to hospital discharge, up to 90 days
30-Day Unplanned Readmission Rate
Proportion of patients who have an unplanned readmission to any hospital within 30 days after hospital discharge
Time frame: 30 days after hospital discharge
Incidence of Resuscitation-Related Serious Adverse Events
Proportion of patients who experience serious adverse events related to fluid resuscitation (e.g., new-onset cardiogenic pulmonary edema, arrhythmia requiring intervention) during the ICU stay
Time frame: From ICU admission until ICU discharge, up to 90 days
Plan to share: No — The investigators may have further research, and the investigators may not consider releasing the research data until the results are announced
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