Racecadotril for Organ Injury in Sepsis Patients

Investigational drug: Racecadotril Granules Study title: Racecadotril for Organ Injury inSepsis Patients: A Single‐Center, Single‐Blind, Randomized, Placebo‐Controlled PilotTrial Principal Investigator: Zhanguo Liu, professor, Department of Critical CareMedicine, Zhujiang Hospital, Southern Medical University Study subjects: Patientsdiagnosed with sepsis according to the SOFA‐2 scoring criteria published by JAMA in 2025(PMID: 41159833).Study objectives: The objective of the study is to determine whether Racecadotril,compared to placebo, improves organ dysfunction scores (SOFA ‐2 scores) in septicpatients.Study design: A single‐center, single‐blind, randomized, placebo‐controlled pilot trial.Method: On the basis of standardized treatment for sepsis, the Racecadotril group will begiven Racecadotril Granules at a dose of 1.5mg/kg reconstituted in 20ml of water fornasal feeding tube, three times daily; the Control group will be given an equal volume ofwater for nasal feeding tube,three times daily, intervention for 4 days or until ICUdischarge(whatever come first).Course: 4 days Sample size: 44 The number of study center: 1Study center:1. Department of Critical Care Medicine of Zhujiang Hospital,Southern MedicalUniversity,Guangzhou, China Primary endpoint: 96‐hour Sequential Organ FailureAssessment‐2 (SOFA‐2) scoreSecondary endpoints: 1. The blood routine examination: White blood cell count, neutrophil count, neutrophilratio, lymphocyte count, lymphocyte ratio, platelet count at 96 h after firsttreatment administration. 2. The state of liver function: the serum level of transaminase (AST and ATL) and totalbilirubin at 96 h after first treatment administration. 3. The state of kidney function: the serum level of Creatinine (Cr)#blood urea nitrogen(BUN)# and daily urine output at 96 h after first treatment administration. 4. The state of circulation system: Blood pressure, the duration and dosage ofvasopressor drugs, and the serum level of lactate at 96 h after first treatmentadministration. 5. The state of lung function: oxygenation index(PaO2/FiO2), partial pressure ofoxygen, partial pressure of carbon dioxide at 96 h after first treatmentadministration. 6. The state of inflammatory response: the serum level of interleukin‐6(L‐6) andC‐reactive protein (CRP) at 96 h after first treatment administration. 7. The state of infection: the serum level of procalcitonin (PCT) at 96 h after firsttreatment administration. 8. The organ function support status: mechanical ventilation, RT treatment status, ECMOsupport status at 96 h after first treatment administration. 9. The critical score: APAPCHE II score at 96 h after first treatment administration.Safety endpoints: 1. Safety evaluation indicators: Possible adverse reactions of Racecadotril may include(drowsiness, rash, constipation, nausea, abdominal pain), survival status on the28th day. 2. Feasibility evaluation indicators: Record the specific number of days and times thatpatients used Racecadotril; ICU hospitalization days.For subjects whose treatment lasts less than 4 days, the changes on the date of ICUdischarge will be used.