Gelaspan vs Crystalloid Therapy in Sepsis
Recruiting
Phase 4
Interventional Study
Sepsis
Intra-Abdominal Infections
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 318 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Other
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About This Trial
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 urg…
Trial Locations
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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 clin…
Contacts