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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• 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
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Not yet recruiting

Study contacts

• Principal investigator: Changhong Miao, MD — Fudan University
• Study coordinator: Jian Huang, MD
• Email: huang.jian1@zs-hospital.sh.cn
• Phone: +8618018684575

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ruta C and Vitamin C in Sepsis: Adding antioxidants to standard care

  This trial tests whether adding Ruta C (rutin plus vitamin C) or vitamin C alone to standard sepsis treatment helps adults in the ICU stay shorter and recover better.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07922213

• Early detection of sepsis-related blood clotting problems in severe burn patients

  This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.

  Recruiting Center for Traumatology and Major Burns, Ben Arous · Tunis · NCT07914205

• Neutrophil EMR3 as a biomarker for sepsis in ICU patients

  Researchers will test whether measuring EMR3 on neutrophils helps diagnose sepsis, monitor progression, and predict outcomes in adults in Chinese ICUs.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang · NCT07896018

• Thymalfasin added to standard care for adults with sepsis and immune dysfunction

  This study tests whether thymosin alpha-1 helps restore immune function in adults with sepsis who have weakened immunity.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07866118

• Multicenter group study of sepsis and ARDS in China

  This study tests how sepsis and ARDS differ among adults across several Chinese hospitals and builds a biobank to understand why some patients do better or worse.

  Recruiting at 24 sites Shanghai Zhongshan Hospital · Xiamen, Fujian and 23 other locations · NCT07863908

• Non-invasive hemodynamic guidance for sepsis care on medical wards

  This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.

  Recruiting at 2 sites Regione del Veneto - AULSS n. 7 Pedemontana · Pisa, Pisa and 1 other locations · NCT07863323

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.