Racecadotril for Organ Injury in Sepsis Patients: A Single-Center, Single-Blind, Randomized, Placebo-Controlled Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 96-hour Sequential Organ Failure Assessment-2 (SOFA-2) score
研究概览
简要总结
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.
详细描述
Investigational drug: Racecadotril Granules Study title: Racecadotril for Organ Injury in Sepsis Patients: A Single-Center, Single-Blind, Randomized, Placebo-Controlled Pilot Trial Principal Investigator: Zhanguo Liu, professor, Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University Study subjects: Patients diagnosed 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 septic patients.
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 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 equal volume of water for nasal feeding tube,three times daily, intervention for 4 days or until ICU discharge(whatever come first).
Course: 4 days Sample size: 44 The number of study center: 1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Water
On the basis of standardized treatment for sepsis, 20ml of water for nasal feeding tube, three times daily for 4 consecutive days
干预措施: Water (Placebo) (Drug)
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.
干预措施: Racecadotril (Drug)
结局指标
主要结局
96-hour Sequential Organ Failure Assessment-2 (SOFA-2) score
时间窗: Day0,Day1,Day2,Day3,Day4,Day5
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.
96-hour Sequential Organ Failure Assessment-2 (SOFA-2) score
时间窗: Day0,Day1,Day2,Day3,Day4
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.
次要结局
- 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)
- blood routine examination(6) - platelet count(Day0,Day1,Day2,Day3,Day4,Day5)
- liver function(1) - ALT(Day0,Day1,Day2,Day3,Day4,Day5)
- liver function(2) - AST(Day0,Day1,Day2,Day3,Day4,Day5)
- liver function(3) - TBil(Day0,Day1,Day2,Day3,Day4,Day5)
- kidney function(1) - Cr(Day0,Day1,Day2,Day3,Day4,Day5)
- kidney function(2) - BUN(Day0,Day1,Day2,Day3,Day4,Day5)
- kidney function(3) - daily urine output(Day0,Day1,Day2,Day3,Day4,Day5)
- circular evaluation index(1) - BP(Day0,Day1,Day2,Day3,Day4,Day5)
- circular evaluation index(2) - the duration and dosage of vasoactive drugs(Day0,Day1,Day2,Day3,Day4,Day5)
- circular evaluation index(3) - Lac(Day0,Day1,Day2,Day3,Day4,Day5)
- lung function(1) - PaO2/FiO2(Day0,Day1,Day2,Day3,Day4,Day5)
- lung function(2) - PaO2(Day0,Day1,Day2,Day3,Day4,Day5)
- lung function(3) - PaCO2(Day0,Day1,Day2,Day3,Day4,Day5)
- inflammatory response(1) - CRP(Day0,Day3(as far as possible),Day5)
- inflammatory response(2) - IL-6(Day0,Day3(as far as possible),Day5)
- Indicators of infection(Day0,Day3(as far as possible),Day5)
- organ function support status(1) - the duration of use of MV(Day0,Day1,Day2,Day3,Day4,Day5)
- organ function support status(2) - The duration of CRRT(Day0,Day1,Day2,Day3,Day4,Day5)
- organ function support status(3) - The duration of ECMO(Day0,Day1,Day2,Day3,Day4,Day5)
- The critical score - APAPCHE II score(Day0,Day1,Day2,Day3,Day4,Day5)
- blood routine examination(1) - white blood cell count(Day0,Day1,Day2,Day3,Day4)
- blood routine examination(2) - neutrophil count(Day0,Day1,Day2,Day3,Day4)
- blood routine examination(3) - neutral cytoplasmic ratio(Day0,Day1,Day2,Day3,Day4)
- blood routine examination(4) - lymphocyte count(Day0,Day1,Day2,Day3,Day4)
- blood routine examination(5) - lymphocyte ratio(Day0,Day1,Day2,Day3,Day4)
- blood routine examination(6) - platelet count(Day0,Day1,Day2,Day3,Day4)
- liver function(1) - ALT(Day0,Day1,Day2,Day3,Day4)
- liver function(2) - AST(Day0,Day1,Day2,Day3,Day4)
- liver function(3) - TBil(Day0,Day1,Day2,Day3,Day4)
- kidney function(1) - Cr(Day0,Day1,Day2,Day3,Day4)
- kidney function(2) - BUN(Day0,Day1,Day2,Day3,Day4)
- kidney function(3) - daily urine output(Day0,Day1,Day2,Day3,Day4)
- circular evaluation index(1) - BP(Day0,Day1,Day2,Day3,Day4)
- inflammatory response(1) - CRP(Day0,Day1,Day2,Day3,Day4)
- circular evaluation index(2) - the duration and dosage of vasoactive drugs(Day0,Day1,Day2,Day3,Day4)
- circular evaluation index(3) - Lac(Day1,Day2,Day3,Day4)
- lung function(1) - PaO2/FiO2(Day0,Day1,Day2,Day3,Day4)
- lung function(2) - PaO2(Day0,Day1,Day2,Day3,Day4)
- lung function(3) - PaCO2(Day0,Day1,Day2,Day3,Day4)
- inflammatory response(2) - IL-6(Day0,Day1,Day2,Day3,Day4)
- Indicators of infection(Day0,Day1,Day2,Day3,Day4)
- organ function support status(1) - the duration of use of MV(Day0,Day1,Day2,Day3,Day4)
- organ function support status(2) - The duration of CRRT(Day0,Day1,Day2,Day3,Day4)
- organ function support status(3) - The duration of ECMO(Day0,Day1,Day2,Day3,Day4)
- The critical score - APAPCHE II score(Day0,Day1,Day2,Day3,Day4)
研究者
Liu Zhanguo
Director of the department of critical care medicine, Principal Investigator
Zhujiang Hospital