Racecadotril for Organ Injury in Sepsis Patients

Sponsor
Zhujiang Hospital
Study ID
NCT07454421
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Racecadotril — DRUG
    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
  • Water (Placebo) — DRUG
    On the basis of standardized treatment for sepsis, 20ml of water for nasal feeding tube, three times daily for 4 consecutive days

Study Details

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.

Key Dates

First listed
Mar 6, 2026
Start date
May 6, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: Water
    On the basis of standardized treatment for sepsis, 20ml of water for nasal feeding tube, three times daily for 4 consecutive days

Primary Outcome Measure

96-hour Sequential Organ Failure Assessment-2 (SOFA-2) score [ Time Frame: Day0,Day1,Day2,Day3,Day4,Day5 ]

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