Condition: Sepsis · Intra-Abdominal Infections · Sponsor: Shanghai Zhongshan Hospital
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 balanced gelatin reduce positive fluid balance within 24 hours after surgery? * Does it improve hemodynamic stability during the early postoperative period? * What effects does balanced gelatin have on kidney function, microcirculation, postoperative recovery, and other clinical outcomes? Participants will be followed throughout hospitalization and contacted again on postoperative day 28 and day 90 to assess survival, complications, and health-related quality of life. The trial is double-blind, meaning that patients, clinicians, and outcome assessors do not know which fluid is being used. An indep…
This description comes directly from the study's public registry record.
Jian Huang, MD · +8618018684575 · huang.jian1@zs-hospital.sh.cn
Jing Zhong, MD · +86-021-64041990 · zhong.jing@zs-hospital.sh.cn
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT07172451