Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07172451

Gelaspan vs Crystalloid Therapy in Sepsis

Led by Shanghai Zhongshan Hospital · Updated on 2026-03-20

318

Participants Needed

9

Research Sites

150 weeks

Total Duration

On this page

Sponsors

S

Shanghai Zhongshan Hospital

Lead Sponsor

B

B. Braun Medical International Trading Company Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Gelaspan vs Crystalloid Therapy in Sepsis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of sepsis from intra-abdominal infection requiring emergency abdominal surgery
  • SOFA score of 2 or higher and blood lactate level greater than 2 mmol/L within 6 hours before enrollment
  • Ability to understand the study and provide written informed consent by the participant or legal representative
Not Eligible

You will not qualify if you...

  • Received any artificial colloid fluids within 24 hours before randomization
  • Expected death within 48 hours (ASA physical status class 5 or higher)
  • Atrial fibrillation or congestive heart failure
  • Severe Acute Respiratory Distress Syndrome (ARDS)
  • Preoperative coagulation problems or currently on anticoagulant therapy
  • Need for renal replacement therapy before surgery (including dialysis)
  • Acute burns covering more than 10% of total body surface area
  • Severe liver impairment
  • Severe electrolyte imbalances
  • Pregnancy or breastfeeding
  • Known allergy to gelatin
  • Currently participating in other interventional clinical trials
  • Any other condition judged by the investigator as unsuitable for participation

AI-Screening

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Trial Site Locations

Total: 9 locations

1

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510080

Not Yet Recruiting

2

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China, 210009

Not Yet Recruiting

3

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Not Yet Recruiting

4

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Not Yet Recruiting

5

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

6

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

Not Yet Recruiting

7

Tianjin Medical University General Hospital

Tianjing, Tianjing, China, 300052

Not Yet Recruiting

8

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310058

Not Yet Recruiting

9

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (WMU)

Wenzhou, Zhejiang, China, 325000

Not Yet Recruiting

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Research Team

J

Jian Huang, MD

CONTACT

J

Jing Zhong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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