Racecadotril for Organ Injury in Sepsis Patients

NCT07454421 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025-KY-547-03
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Sepsis

Keywords

Sepsis; Racecadotril; organ dysfunction

Outcome Measures

Primary Outcomes (1)

• 96-hour Sequential Organ Failure Assessment-2 (SOFA-2) score

  The SOFA-2 score is the Sequential Organ Failure Score-2, which is used to assess a patient's prognosis by determining the degree of impairment of major organ function. The score is divided into 6 sections: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal, and ranges from 0 to 4, resulting in a total score ranging from a minimum of 0 to a maximum of 24 points, with higher SOFA-2 scores associated with a higher incidence of poor prognosis.

  Day0,Day1,Day2,Day3,Day4,Day5

Secondary Outcomes (25)

• blood routine examination(1) - white blood cell count

  Day0,Day1,Day2,Day3,Day4,Day5

• blood routine examination(2) - neutrophil count

  Day0,Day1,Day2,Day3,Day4,Day5

• blood routine examination(3) - neutral cytoplasmic ratio

  Day0,Day1,Day2,Day3,Day4,Day5

• blood routine examination(4) - lymphocyte count

  Day0,Day1,Day2,Day3,Day4,Day5

• blood routine examination(5) - lymphocyte ratio

  Day0,Day1,Day2,Day3,Day4,Day5

Other Outcomes (3)

• Incidence of adverse events

  Day0,Day1,Day2,Day3,Day4,Day5

• Feasibility evaluation indicators(1) - Frequency and duration of Racecadotril use

  Day0,Day1,Day2,Day3,Day4,Day5

• Feasibility evaluation indicators(2) - ICU hospitalization days

  through the ICU hospitalization up to day 4

Study Arms (2)

Racecadotril

EXPERIMENTAL

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: Racecadotril

Water

PLACEBO COMPARATOR

On the basis of standardized treatment for sepsis, 20ml of water for nasal feeding tube, three times daily for 4 consecutive days

Drug: Water (Placebo)

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

Racecadotril

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

Water

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Guanzhou, Guangdong, China

Location

Related Publications (1)

• Ranzani OT, Singer M, Salluh JIF, Shankar-Hari M, Pilcher D, Berger-Estilita J, Coopersmith CM, Juffermans NP, Laffey J, Reinikainen M, Neto AS, Tavares M, Timsit JF, Arias Lopez MDP, Arulkumaran N, Aryal D, Azoulay E, Celi LA, Chaudhuri D, De Lange D, De Waele J, Dos Santos CC, Du B, Einav S, Engelbrecht T, Fazla F, Ferrer R, Finazzi S, Fujii T, Gershengorn HB, Greene JD, Haniffa R, Hao S, Hasan MS, Hollenberg S, Ippolito M, Jung C, Kirov M, Kobari S, Lakbar I, Lipman J, Liu V, Liu X, Lobo SM, Magatti D, Martin GS, Metnitz B, Metnitz P, Myatra SN, Oczkowski S, Paiva JA, Paruk F, Pekkarinen PT, Piquilloud L, Polkki A, Prescott HC, Blaser AR, Rezende E, Robba C, Rochwerg B, Ruckly S, Samei R, Schenck EJ, Secombe P, Sendagire C, Siaw-Frimpong M, Simpkin AJ, Soares M, Summers C, Szczeklik W, Takala J, Tanaka S, Tricella G, Vincent JL, Wendon J, Zampieri FG, Rhodes A, Moreno R. Development and Validation of the Sequential Organ Failure Assessment (SOFA)-2 Score. JAMA. 2025 Dec 16;334(23):2090-2103. doi: 10.1001/jama.2025.20516.

  PMID: 41159833 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

racecadotril; Water

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Zhanguo Liu, M.D.PhD

  Department of Critical Care Medicine of Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhanguo Liu, M.D.PhD

CONTACT

+86 020 62782927; zhguoliu@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of critical care medicine, Principal Investigator

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)