Gelaspan vs Crystalloid Therapy in Sepsis

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.

Conditions

• Sepsis
• Intra-Abdominal Infections

Interventions

DRUG

Balanced Gelatin Solution

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.

DRUG

Acetate Ringer's 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.

Sponsors & Collaborators

• B. Braun Medical International Trading Company Ltd.

  collaborator INDUSTRY

• Shanghai Zhongshan Hospital

  lead OTHER

Principal Investigators

• Changhong Miao, MD · Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-13

Primary Completion

2028-09-30

Completion

2028-12-30

Countries

• China

Study Locations