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โ† Trials
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Gelaspan vs Crystalloid Therapy in Sepsis

RecruitingPhase 4Ages 18 Years - anyAllShanghai Zhongshan Hospital
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In plain words

What the trial is, and whether it could suit you

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 balan

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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 โ‰ฅ 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 โ‰ฅ 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.
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What it tests

  • Balanced Gelatin Solution
  • Acetate Ringer's Solution
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Where

9 sites
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Zhongda Hospital, Southeast University
Nanjing, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Zhongshan Hospital, Fudan University
Shanghai, China
West China Hospital of Sichuan University
Chengdu, China
Tianjin Medical University General Hospital
Tianjing, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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