Balanced gelatin versus crystalloid therapy for perioperative sepsis in emergency abdominal surgery

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

This study will test if a balanced gelatin solution helps adults with sepsis undergoing emergency abdominal surgery keep blood volume and recover better than Ringer's acetate.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 318 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 9 sites (Guangzhou, Guangdong and 8 other locations)
• Trial ID: NCT07172451 on ClinicalTrials.gov

What this trial studies

Adult patients with sepsis from intra-abdominal infection who require emergency abdominal surgery are randomized 1:1 to receive either a balanced gelatin colloid or Ringer's acetate during the operation and for the first 24 hours afterward. All participants receive standardized anesthesia, goal-directed fluid therapy, and protocolized vasoactive drug use to keep other care consistent. The trial measures early fluid balance (24-hour positive fluid balance), hemodynamic stabilization, and safety outcomes including coagulation and renal function. This phase 4 multicenter trial is conducted at several tertiary hospitals in China.

Who should consider this trial

Good fit: Adults (≥18) with Sepsis-3 sepsis due to intra-abdominal infection who need emergency abdominal surgery, have SOFA ≥2 and lactate >2 mmol/L, and can provide informed consent are eligible.

Not a fit: Patients with atrial fibrillation, congestive heart failure, severe ARDS, recent artificial colloid use, active coagulation disorders, or on chronic/intermittent renal replacement therapy are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, balanced gelatin could reduce fluid overload and improve blood pressure and organ perfusion after emergency abdominal surgery for sepsis.

How similar studies have performed: Previous comparisons of colloids versus crystalloids have shown mixed results and high-quality evidence specific to gelatin is limited, so this approach remains incompletely proven.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Guangzhou, Guangdong and 8 other locations

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

Study contacts

• Principal investigator: Changhong Miao, MD — Fudan University
• Study coordinator: Jian Huang, MD

Conditions Sepsis; Intra-Abdominal Infections; Balanced gelatin solution; Succinylated gelatin; Crystalloid; Ringer's acetate; Fluid resuscitation; Goal-directed fluid therapy