Clinical Trial

Racecadotril for Organ Injury in Sepsis Patients

Study acronym: ROISP
Enrolling by Invitation Phase 1/2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-05-29
Trial Details
NCT Number NCT07454421
Lead Sponsor Zhujiang Hospital
Conditions Sepsis
Enrollment 44 participants
Start Date 2026-05-06
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-28