Status:
NOT_YET_RECRUITING
Gelaspan vs Crystalloid Therapy in Sepsis
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
B. Braun Medical International Trading Company Ltd.
Conditions:
Sepsis
Intra-Abdominal Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 w...
Detailed Description
Study Background Sepsis is a life-threatening syndrome caused by a dysregulated host response to severe infection, which can rapidly progress to septic shock, multiple organ dysfunction, and death.Des...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Diagnosis of sepsis according to Sepsis-3 definition.
- Scheduled for emergency non-cardiac surgery under general anesthesia.
- Randomization and study intervention can be initiated before skin incision.
- Provision of written informed consent by patient or legal representative.
Exclusion
- Cardiac surgery, neurosurgery, or procedures requiring cardiopulmonary bypass.
- Severe preexisting cardiac dysfunction (ejection fraction \<30%, NYHA class IV).
- End-stage renal disease requiring chronic renal replacement therapy.
- Known severe hepatic failure (Child-Pugh C).
- Known allergy or contraindication to study fluids (gelatin solution or crystalloid solution).
- Pregnant or lactating women.
- Participation in another interventional trial within the past 30 days.
- Life expectancy \<24 hours or decision to withhold/withdraw life-sustaining treatment.
Key Trial Info
Start Date :
December 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT07172451
Start Date
December 20 2025
End Date
December 30 2028
Last Update
December 11 2025
Active Locations (9)
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1
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
2
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009
3
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
4
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000