Gelaspan vs Crystalloid Therapy in Sepsis
Efficacy and Safety of Balanced Gelatin Solution for Fluid Infusion in Sepsis Patients Undergoing Emergency Abdominal Surgery: A Multicenter, Adaptive Designed, Randomized Controlled Trial
Shanghai Zhongshan Hospital
318 participants
Feb 13, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Age ≥ 18 years.
- Diagnosis of sepsis according to the Sepsis-3 definition, caused by intra-abdominal infection, and requiring emergency abdominal surgery for source control.
- Sequential Organ Failure Assessment (SOFA-2) score ≥ 2 (determined by the most recent available clinical data) and blood lactate \> 2 mmol/L (measured within 6 hours prior to enrollment).
- Subject or legal representative can understand the study purpose and provide written informed consent.
Exclusion Criteria13
- Received any dose of artificial colloids within 24 hours prior to randomization.
- Predicted mortality within 48 hours (ASA physical status class ≥ V).
- Atrial fibrillation or congestive heart failure.
- Severe Acute Respiratory Distress Syndrome (ARDS).
- Preoperative coagulation dysfunction or receiving anticoagulant therapy.
- Preoperative requirement for renal replacement therapy (long-term or intermittent, including hemodialysis or peritoneal dialysis).
- Acute burns exceeding 10% of the total body surface area.
- Severe hepatic impairment.
- Severe electrolyte disturbance.
- Pregnancy or breastfeeding.
- Known allergy to gelatin.
- Current participation in other interventional clinical trials.
- Other conditions that the investigator considers inappropriate for inclusion.
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Interventions
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.
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.
Locations(9)
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NCT07172451