Racecadotril for Organ Injury in Sepsis Patients

Enrolling by invitation · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Sepsis

In brief

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 facts

Study ID

NCT07454421

Run by

Zhujiang Hospital

People needed

44

Starts

2026-05-06

Expected to finish

2027-12-31

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosed with sepsis according to the SOFA-2 scoring criteria published in 2025 JAMA(PMID:41159833);
• SOFA-2 score: 6 - 14 points;
• subjects who voluntarily participated in this study and signed an informed consent form.
• age 18 - 80 years.

You may not qualify if…

• Patients with a known allergy to the study product.
• Patients unable to receive enteral nutrition via a gastrointestinal tube.
• Patients with hepatic insufficiency: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels both greater than 3 times the upper limit of normal.
• Patients with renal dysfunction: Acute kidney injury (AKI) ; chronic kidney disease (CKD) stage 3 or higher.
• Patients receiving medications at the start of the study that may significantly interfere with the pharmacodynamics and metabolism of Racecadotril, or increase its toxicity(Such as Erythromycin, Ketoconazole, Rifampicin).
• Patients with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.
• Pregnant or breastfeeding women.
• Patients with limited nursing care (patients for whom active treatment has been withdrawn).

Where it is running

• Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University — Guanzhou, Guangdong, China

Full record on ClinicalTrials.gov

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