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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Zhongda Hospital, Southeast University
NOT_YET_RECRUITING
Nanjing
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjing
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (WMU)
NOT_YET_RECRUITING
Wenzhou
Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Contact Information
Primary
Jian Huang, MD
huang.jian1@zs-hospital.sh.cn
+8618018684575
Backup
Jing Zhong, MD
zhong.jing@zs-hospital.sh.cn
+86-021-64041990
Time Frame
Start Date: 2026-02-13
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 318
Treatments
Experimental: Balanced Gelatin Solution
Patients randomized to the balanced gelatin group receive balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier) for volume expansion during the surgical procedure, guided by a stroke volume (SV) monitoring protocol. The study fluid management may continue for up to 24 hours post-randomization according to clinical needs. The cumulative dose of balanced gelatin is capped at 30 mL/kg (ideal body weight) within the first 24 hours; once reached or when the study fluid is unavailable, Ringer's acetate is used for subsequent resuscitation.
Active_comparator: Crystalloid Solution
Patients randomized to the crystalloid group receive acetate Ringer's solution as the sole resuscitation fluid during emergency abdominal surgery for sepsis, according to the same goal-directed protocol guided by stroke volume monitoring. No gelatin solution or lactate-containing crystalloids will be administered within the first 24 hours post-randomization. The total volume of crystalloid infusion is not limited.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital
Collaborators: B. Braun Medical International Trading Company Ltd.

This content was sourced from clinicaltrials.gov