Racecadotril for Organ Injury in Sepsis Patients
NCT07454421 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2026-04-28
Summary
In this single-center, single-blind, randomized, placebo-controlled pilot trial. The effect of Racecadotril on the improvement of organ function will be investigated in patients with sepsis. Researchers will screen patients admitted to the Department of Critical Care Medicine at Zhujiang Hospital to identify patients with sepsis based on including and excluding criteria and obtain informed consent and randomize them into groups.
On the basis of standardized treatment for sepsis, the Racecadotril group will be given Racecadotril Granules at a dose of 1.5mg/kg reconstituted in 20ml of water for nasal feeding tube, three times daily; the Control group will be given an 20ml of water for nasal feeding tube,three times daily. The changes in SOFA-2 score and other clinically meaningful outcomes in 4 days will be collected. For subjects whose treatment lasts less than 4 days, the changes on the date of ICU discharge will be used.
Conditions
Interventions
- DRUG
-
Racecadotril
On the basis of standardized treatment for sepsis, the Racecadotril group will be given Racecadotril Granules at a dose of 1.5mg/kg reconstituted in 20ml of water for nasal feeding tube, three times daily for 4 consecutive days
- DRUG
-
Water (Placebo)
On the basis of standardized treatment for sepsis, 20ml of water for nasal feeding tube, three times daily for 4 consecutive days
Sponsors & Collaborators
-
Zhujiang Hospital
lead OTHER
Principal Investigators
-
Zhanguo Liu, M.D.PhD · Department of Critical Care Medicine of Zhujiang Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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