Gelaspan vs Crystalloid Therapy in Sepsis

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

December 30, 2028

Conditions
SepsisIntra-Abdominal Infections
Interventions
DRUG

Balanced Gelatin Solution

Balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier). Administered as resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Infusion follows a stroke volume-guided, goal-directed fluid therapy protocol. The total dose is limited to 30 mL/kg (ideal body weight) during the intraoperative period and the first 24 postoperative hours. If the maximum dose is reached, additional resuscitation is provided with balanced crystalloid solution.

DRUG

Acetate Ringer's Solution

Acetate Ringer's solution, a balanced crystalloid, administered as the sole resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Fluid therapy follows the same stroke volume-guided, goal-directed protocol as the experimental arm. There is no upper limit for the total volume of crystalloid infusion during the intraoperative and first 24 postoperative hours.

Trial Locations (9)

200032

Zhongshan Hospital, Fudan University, Shanghai

200433

The First Affiliated Hospital of Naval Military Medical University, Shanghai

210009

Zhongda Hospital, Southeast University, Nanjing

215006

The First Affiliated Hospital of Soochow University, Suzhou

221000

Affiliated Hospital of Xuzhou Medical University, Xuzhou

250021

Shandong Provincial Hospital, Jinan

300052

Tianjin Medical University General Hospital, Tianjing

310058

The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

510080

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
collaborator

B. Braun Medical International Trading Company Ltd.

INDUSTRY

lead

Shanghai Zhongshan Hospital

OTHER