Clinical Research Directory

Gelaspan vs Crystalloid Therapy in Sepsis

Sponsor: Shanghai Zhongshan Hospital

Summary

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: * Does balanced gelatin reduce positive fluid balance within 24 hours after surgery? * Does it improve hemodynamic stability during the early postoperative period? * What effects does balanced gelatin have on kidney function, microcirculation, postoperative recovery, and other clinical outcomes? 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.

Official title: Efficacy and Safety of Balanced Gelatin Solution for Fluid Infusion in Sepsis Patients Undergoing Emergency Abdominal Surgery: A Multicenter, Adaptive Designed, Randomized Controlled Trial

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