Gelaspan vs Crystalloid Therapy in Sepsis

Recruiting now · Phase 4

Conditions studied: Sepsis, Intra-Abdominal Infections

In brief

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.

Key facts

Study ID

NCT07172451

Run by

Shanghai Zhongshan Hospital

People needed

318

Starts

2026-02-13

Expected to finish

2028-12-30

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
• Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China
• West China Hospital of Sichuan University — Chengdu, Sichuan, China
• Tianjin Medical University General Hospital — Tianjing, Tianjing, China
• The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (WMU) — Wenzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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