SepsisPhase 1/2ROISPNCT07454421
Racecadotril for Organ Injury in Sepsis Patients
A Phase 1/2 study testing Racecadotril in people with Sepsis, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Racecadotril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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- Patients with limited nursing care (patients for whom active treatment has been withdrawn).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guanzhou, Guangdong
About this study
Official title: Racecadotril for Organ Injury in Sepsis Patients: A Single-Center, Single-Blind, Randomized, Placebo-Controlled Pilot Trial
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.
Read the detailed description
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
Study center:
- Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University,Guangzhou, China Primary endpoint: 96-hour Sequential Organ Failure Assessment-2 (SOFA-2) score
Secondary endpoints:
- The blood routine examination: White blood cell count, neutrophil count, neutrophil ratio, lymphocyte count, lymphocyte ratio, platelet count at 96 h after first treatment administration.
- The state of liver function: the serum level of transaminase (AST and ATL) and total bilirubin at 96 h after first treatment administration.
- 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.
- The state of circulation system: Blood pressure, the duration and dosage of vasopressor drugs, and the serum level of lactate at 96 h after first treatment administration.
- The state of lung function: oxygenation index(PaO2/FiO2), partial pressure of oxygen, partial pressure of carbon dioxide at 96 h after first treatment administration.
- The state of inflammatory response: the serum level of interleukin-6(L-6) and C-reactive protein (CRP) at 96 h after first treatment administration.
- The state of infection: the serum level of procalcitonin (PCT) at 96 h after first treatment administration.
- The organ function support status: mechanical ventilation, RT treatment status, ECMO support status at 96 h after first treatment administration.
- The critical score: APAPCHE II score at 96 h after first treatment administration.
Safety endpoints:
- Safety evaluation indicators: Possible adverse reactions of Racecadotril may include (drowsiness, rash, constipation, nausea, abdominal pain), survival status on the 28th day.
- Feasibility evaluation indicators: Record the specific number of days and times that patients used Racecadotril; ICU hospitalization days.
For subjects whose treatment lasts less than 4 days, the changes on the date of ICU discharge will be used.
- Conditions
- Sepsis
- Being tested
- Racecadotril, Water (Placebo)
- Keywords
- Sepsis, Racecadotril, organ dysfunction
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RacecadotrilDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Water (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day0,Day1,Day2,Day3,Day4,Day5
Secondary outcomes (25)
blood routine examination(1) - white blood cell count
white blood cell count
Measured: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(2) - neutrophil count
neutrophil count
Measured: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(3) - neutral cytoplasmic ratio
neutral cytoplasmic ratio
Measured: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(4) - lymphocyte count
lymphocyte count
Measured: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(5) - lymphocyte ratio
lymphocyte ratio
Measured: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(6) - platelet count
platelet count
Measured: Day0,Day1,Day2,Day3,Day4,Day5
liver function(1) - ALT
the serum level of Alanine transaminase(ALT)
Measured: Day0,Day1,Day2,Day3,Day4,Day5
liver function(2) - AST
the serum level of Aspartate transaminase (AST)
Measured: Day0,Day1,Day2,Day3,Day4,Day5
liver function(3) - TBil
the serum level of total bilirubin(TBil)
Measured: Day0,Day1,Day2,Day3,Day4,Day5
kidney function(1) - Cr
serum level of Creatinine (Cr)
Measured: Day0,Day1,Day2,Day3,Day4,Day5
kidney function(2) - BUN
serum level of blood urea nitrogen(BUN)
Measured: Day0,Day1,Day2,Day3,Day4,Day5
kidney function(3) - daily urine output
daily urine output in milliliters from 0:00 - 24:00
Measured: Day0,Day1,Day2,Day3,Day4,Day5
circular evaluation index(1) - BP
blood pressure
Measured: Day0,Day1,Day2,Day3,Day4,Day5
circular evaluation index(2) - the duration and dosage of vasoactive drugs
the duration and dosage of vasoactive drugs. The duration from the vasoactive drugs administration to the successful cessation in hours( The successful cessation is defined as the attainment of a clinician-prescribed mean arterial pressure target for more than 24-hours without the use of vasoactive drugs. This outcome measure is intended only for patients receiving vasoactive drugs)
Measured: Day0,Day1,Day2,Day3,Day4,Day5
circular evaluation index(3) - Lac
the serum level of lactic acid
Measured: Day0,Day1,Day2,Day3,Day4,Day5
lung function(1) - PaO2/FiO2
oxygenation index(PaO2/FiO2),the patients treated with extracorporeal membrane oxygenation will not collect this indicator
Measured: Day0,Day1,Day2,Day3,Day4,Day5
lung function(2) - PaO2
oxygen partial pressure(PaO2)
Measured: Day0,Day1,Day2,Day3,Day4,Day5
lung function(3) - PaCO2
partial pressure of carbon dioxide(PaCO2)
Measured: Day0,Day1,Day2,Day3,Day4,Day5
inflammatory response(1) - CRP
the serum level of C-reactive protein(CRP)
Measured: Day0,Day3(as far as possible),Day5
inflammatory response(2) - IL-6
the serum level of interleukin-6(IL-6)
Measured: Day0,Day3(as far as possible),Day5
Indicators of infection
the serum level of procalcitonin(PCT)
Measured: Day0,Day3(as far as possible),Day5
organ function support status(1) - the duration of use of MV
the duration of use of mechanical ventilation (MV).The duration from the MV administration to the successful cessation in hours( The successful cessation is defined as the termination of MV for more than 48-hours. This outcome measure is intended only for patients receiving MV)
Measured: Day0,Day1,Day2,Day3,Day4,Day5
organ function support status(2) - The duration of CRRT
The duration of CRRT.The duration of CRRT therapy in hours
Measured: Day0,Day1,Day2,Day3,Day4,Day5
organ function support status(3) - The duration of ECMO
The duration of ECMO.The duration of ECMO therapy in hours
Measured: Day0,Day1,Day2,Day3,Day4,Day5
The critical score - APAPCHE II score
APAPCHE II score （Acute Physiology and Chronic Health Evaluation II） has a scoring range of 0 to 71 points. A higher score indicates a worse outcome, signifying a more critical patient condition and a correspondingly increased risk of mortality. It is a commonly used tool in Intensive Care Units (ICUs) for assessing the severity of a patient's illness and predicting prognosis.
Measured: Day0,Day1,Day2,Day3,Day4,Day5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start6 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhanguo, Zhujiang Hospital
- Investigators
- Zhanguo Liu, M.D.PhD, Principal investigator, Department of Critical Care Medicine of Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454421
- Sponsor's protocol ID
- 2025-KY-547-03
- Acronym
- ROISP
- Status last verified
- May 2026
- First submitted
- 23 Feb 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41159833
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racecadotril for Organ Injury in Sepsis Patients: A Single-Center, Single-Blind, Randomized, Placebo-Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07454421
- Acronym / sponsor ID
- ROISP / 2025-KY-547-03
- Conditions
- Sepsis
- Keywords
- Sepsis, Racecadotril, organ dysfunction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study center:
- Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University,Guangzhou, China Primary endpoint: 96-hour Sequential Organ Failure Assessment-2 (SOFA-2) score
Secondary endpoints:
- The blood routine examination: White blood cell count, neutrophil count, neutrophil ratio, lymphocyte count, lymphocyte ratio, platelet count at 96 h after first treatment administration.
- The state of liver function: the serum level of transaminase (AST and ATL) and total bilirubin at 96 h after first treatment administration.
- 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.
- The state of circulation system: Blood pressure, the duration and dosage of vasopressor drugs, and the serum level of lactate at 96 h after first treatment administration.
- The state of lung function: oxygenation index(PaO2/FiO2), partial pressure of oxygen, partial pressure of carbon dioxide at 96 h after first treatment administration.
- The state of inflammatory response: the serum level of interleukin-6(L-6) and C-reactive protein (CRP) at 96 h after first treatment administration.
- The state of infection: the serum level of procalcitonin (PCT) at 96 h after first treatment administration.
- The organ function support status: mechanical ventilation, RT treatment status, ECMO support status at 96 h after first treatment administration.
- The critical score: APAPCHE II score at 96 h after first treatment administration.
Safety endpoints:
- Safety evaluation indicators: Possible adverse reactions of Racecadotril may include (drowsiness, rash, constipation, nausea, abdominal pain), survival status on the 28th day.
- Feasibility evaluation indicators: Record the specific number of days and times that patients used Racecadotril; ICU hospitalization days.
For subjects whose treatment lasts less than 4 days, the changes on the date of ICU discharge will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Racecadotril | Experimental | Drug: RacecadotrilOn 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 comparator | Drug: Water (Placebo)On the basis of standardized treatment for sepsis, 20ml of water for nasal feeding tube, three times daily for 4 consecutive days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RacecadotrilOn 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)On the basis of standardized treatment for sepsis, 20ml of water for nasal feeding tube, three times daily for 4 consecutive days | Drug | Water |
Primary outcome
96-hour Sequential Organ Failure Assessment-2 (SOFA-2) score
Time frame: 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.
25 secondary outcomes
blood routine examination(1) - white blood cell count
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(2) - neutrophil count
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(3) - neutral cytoplasmic ratio
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(4) - lymphocyte count
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(5) - lymphocyte ratio
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
blood routine examination(6) - platelet count
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
liver function(1) - ALT
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
liver function(2) - AST
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
liver function(3) - TBil
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
kidney function(1) - Cr
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
kidney function(2) - BUN
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
kidney function(3) - daily urine output
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
circular evaluation index(1) - BP
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
circular evaluation index(2) - the duration and dosage of vasoactive drugs
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
circular evaluation index(3) - Lac
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
lung function(1) - PaO2/FiO2
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
lung function(2) - PaO2
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
lung function(3) - PaCO2
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
inflammatory response(1) - CRP
Time frame: Day0,Day3(as far as possible),Day5
inflammatory response(2) - IL-6
Time frame: Day0,Day3(as far as possible),Day5
Indicators of infection
Time frame: Day0,Day3(as far as possible),Day5
organ function support status(1) - the duration of use of MV
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
organ function support status(2) - The duration of CRRT
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
organ function support status(3) - The duration of ECMO
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
The critical score - APAPCHE II score
Time frame: Day0,Day1,Day2,Day3,Day4,Day5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 41159833Ranzani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhanguo Liu, M.D.PhD principal investigator
Department of Critical Care Medicine of Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Racecadotril in people with Sepsis, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
96-hour Sequential Organ Failure Assessment-2 (SOFA-2) score (time frame: Day0,Day1,Day2,Day3,Day4,Day5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07454421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.