Adult Patients With Septic Shock Admitted in Intensive Care UnitRIPOST-sepsisNCT07273942
Remote Ischemic Postconditioning in Septic Shock
A study testing Remote ischemic conditioning in people with Adult Patients With Septic Shock Admitted in Intensive Care Unit, run by Hospices Civils de Lyon at 23 sites in France.
Trial summary
Septic shock is a leading cause of death worldwide despite intensive research efforts. Only a few interventions have been proven to be effective in improving patient-centered outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients With Septic Shock Admitted in Intensive Care Unit
- What is being tested?
- Remote ischemic conditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 23 sitesFrance
- Study dates
- Jan 2027to Apr 2029
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Hospitalized in intensive care unit for less than 24 hours
- Septic shock (Sepsis-3 definition) evolving for less than 18 hours
- Preliminary written informed consent obtained from the patient or his/her close relative, or use of the emergency procedure in accordance with local regulations
Who cannot join
- Contraindication of the use of a brachial pressure cuff on both arms
- Cardiac arrest
- Pregnancy or breast feeding
- Participation in another interventional study
- Lack of French national health insurance coverage
- Patient with any legal protection measure
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
France23 sites
Service de Réanimation Médicale, Hôpital Jean-Minjoz, CHU de Besançon
Besançon, 25030
Gaël PITON, MD
Service Réanimation Polyvalente, Centre Hospitalier de Fleyriat
Bourg-en-Bresse, 01012
François DHELFT, MD
Service de Médecine Intensive- Réanimation, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Maxime DUMESNIL, MD
Service de Médecine Intensive-Réanimation, Hôpital Henri Mondor, Assistance Publique des Hôpitaux de Paris
Créteil, 94000
Armand MEKONTSO-DESSAP, MD
Service de Médecine intensive-Réanimation,Hôpital F Mitterrand, CHU de Dijon
Dijon, 21079
Jean-Pierre QUENOT, MD
Service de Médecine intensive-Réanimation,Hôpital Albert Michallon, CHU de Grenoble
La Tronche, 38700
Carole SCHWEBEL, MD
Service de Médecine Intensive-Réanimation, Hôpital Bicêtre, Assistance Publique des Hôpitaux de Paris
Le Kremlin-Bicêtre, 94270
Tai PHAM, MD
Service de Médecine Intensive-Réanimation, Hôpital Salengro, CHU de Lille
Lille, 59037
Raphaël FAVORY, MD
Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69003
Martin COUR, MD
Service Réanimation Polyvalente, Hôpital Saint-Joseph Saint-Luc
Lyon, 69007
Emmanuel VIVIER, MD
Service de Médecine Intensive-Réanimation, Hôpital Nord, Assistance Publique des Hôpitaux de Marseille
Marseille, 13015
Sami HRAIECH, MD
Service de Réanimation des Urgences, Hôpital de la Timone, CHU de Marseille
Marseille, 13385
Marc GAINNIER, MD
Service de Médecine intensive-Réanimation, Hôpital Lapeyronie, CHU de Montpellier
Montpellier, 34295
Kada KLOUCHE, MD
Service de Médecine Intensive-Réanimation, Hôpital Central, CHRU de Nancy
Nancy, 54035
Sébastien GIBOT, MD
Service de Médecine Intensive-Réanimation, Hôtel Dieu, CHU de Nantes
Nantes, 44093
Jean REIGNIER, MD
Service de Médecine Intensive - Réanimation, Hôpital Cochin, Assistance Publique des Hôpitaux de Paris
Paris, 75014
Jean-Paul MIRA, MD
Service d'Anesthésie - Réanimation - Médecine Intensive, Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495
Auguste DARGENT, MD
Service de Médecine Intensive et Réanimation Polyvalente, Hôpital Robert Debré, CHU Reims
Reims, 51090
David BUSSY, MD
Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes
Rennes, 35000
Félicie BELICARD, MD
Service Réanimation Polyvalente, Centre Hospitalier de Roanne
Roanne, 42328
Pascal BEURET, MD
Service de Médecine intensive-Réanimation, Hôpital Nord, CHU de St Etienne
Saint-Priest-en-Jarez, 42270
Sophie PERINEL, MD
Service de Médecine Intensive-Réanimation, Nouvel Hôpital Civil, CHU de Strasbourg
Strasbourg, 67091
Hamid MERDJI, MD
Service de Médecine Intensive-Réanimation, Hôpital Bretonneau, CHRU de Tours
Tours, 37000
Juliette POCQUET, MD
About this study
Septic shock is a leading cause of death worldwide despite intensive research efforts. Only a few interventions have been proven to be effective in improving patient-centered outcomes. Recent clinical trials have reported the safety and efficacy of remote ischemic postconditioning (RIPOST) in a variety of pathologies, including myocardial infarction, cardiac surgery, and stroke. While RIPOST was mainly tested in pathologies with low mortality rates, several follow-up studies of large randomized clinical trials in acute myocardial infarction and in patients undergoing coronary artery bypass surgery have reported significant decreases (> 50%) in long-term mortality. Experimental studies and proof-of-concept clinical trials have also suggested the potential benefits of RIPOST on mortality in sepsis and septic shock. The present protocol aims to test whether this non-invasive, widely available, inexpensive, and innovative intervention can improve survival in septic shock.
- Being tested
- Remote ischemic conditioning, No intervention
- Keywords
- Septic shock, Remote conditioning, Ischemic conditioning, Ischemia-reperfusion, Intensive care unit
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningOther
A brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of alternating inflations and deflations of the brachial cuff. Four cycles of ischemic conditioning (5-min brachial cuff inflation at 200 mmHg followed by 5-min cuff deflation) are started as soon as possible after inclusion. The intervention is repeated 12 and 24 hours after inclusion.
No interventionOther
No intervention will be performed in the conrol group
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Experimental | A brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of alternating inflations and deflations of the brachial cuff. Four cycles of ischemic conditioning (5-min brachial cuff inflation at 200 mmHg followed by 5-min cuff deflation) are started as soon as possible after inclusion. The intervention is repeated 12 and 24 hours after inclusion. Receives: Other: Remote ischemic conditioning |
| Control group | Other | No intervention wil be performed in the control group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at day 90 after inclusion
Measured: 90 days after inclusion
Secondary outcomes (5)
Functional recovery
Number of days alive after discharge at home by day 90
Measured: Day 90
SF-36 (Short Form-36 Health Survey) questionnaire score
Quality of livre is evaluated by SF-36 (Short Form-36 Health Survey) questionnaire at day 90
Measured: Day 90
Number of days alive without vasopressors
Measured: Day 7
Sepsis-related Organ Failure Assessment (SOFA) score
The severity of multiple organ failure assessed by the Sepsis-related Organ Failure Assessment (SOFA) score
Measured: Inclusion and days 1, 3 and 7
Sepsis-induced immuno-inflammatory responses
Dosage of inflammation biomarkers
- Neutrophils to lymphocytes ratio for all patients
- In about 100 patients (from two centers) with a biological collection, markers of inflammatory/immune response (including cytokines, monocyte HLA-DR (Human Leukocyte Antigen) expression, immature neutrophils)
Measured: Inclusion and days 1, 3 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study startJan 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Septic Shock Admitted in Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273942
- Sponsor's protocol ID
- 69HCL24_0937
- Acronym
- RIPOST-sepsis
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Postconditioning in Septic Shock
- ClinicalTrials.gov ID
- NCT07273942
- Acronym / sponsor ID
- RIPOST-sepsis / 69HCL24_0937
- Keywords
- Septic shock, Remote conditioning, Ischemic conditioning, Ischemia-reperfusion, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 10 Dec 2025 (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.
Septic shock is a leading cause of death worldwide despite intensive research efforts. Only a few interventions have been proven to be effective in improving patient-centered outcomes. Recent clinical trials have reported the safety and efficacy of remote ischemic postconditioning (RIPOST) in a variety of pathologies, including myocardial infarction, cardiac surgery, and stroke. While RIPOST was mainly tested in pathologies with low mortality rates, several follow-up studies of large randomized clinical trials in acute myocardial infarction and in patients undergoing coronary artery bypass surgery have reported significant decreases (> 50%) in long-term mortality. Experimental studies and proof-of-concept clinical trials have also suggested the potential benefits of RIPOST on mortality in sepsis and septic shock. The present protocol aims to test whether this non-invasive, widely available, inexpensive, and innovative intervention can improve survival in septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Experimental | Other: Remote ischemic conditioningA brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of alternating inflations and deflations of the brachial cuff. Four cycles of ischemic conditioning (5-min brachial cuff inflation at 200 mmHg followed by 5-min cuff deflation) are started as soon as possible after inclusion. The intervention is repeated 12 and 24 hours after inclusion. |
| Control group | Other | Other: No interventionNo intervention wil be performed in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Hospitalized in intensive care unit for less than 24 hours
- Septic shock (Sepsis-3 definition) evolving for less than 18 hours
- Preliminary written informed consent obtained from the patient or his/her close relative, or use of the emergency procedure in accordance with local regulations
Key exclusion criteria (6 listed)
- Contraindication of the use of a brachial pressure cuff on both arms
- Cardiac arrest
- Pregnancy or breast feeding
- Participation in another interventional study
- Lack of French national health insurance coverage
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 |
|---|---|---|
| Remote ischemic conditioningA brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of alternating inflations and deflations of the brachial cuff. Four cycles of ischemic conditioning (5-min brachial cuff inflation at 200 mmHg followed by 5-min cuff deflation) are started as soon as possible after inclusion. The intervention is repeated 12 and 24 hours after inclusion. | Other | Remote ischemic conditioning |
| No interventionNo intervention will be performed in the conrol group | Other | Control group |
Primary outcome
All-cause mortality at day 90 after inclusion
Time frame: 90 days after inclusion
5 secondary outcomes
Functional recovery
Time frame: Day 90
SF-36 (Short Form-36 Health Survey) questionnaire score
Time frame: Day 90
Number of days alive without vasopressors
Time frame: Day 7
Sepsis-related Organ Failure Assessment (SOFA) score
Time frame: Inclusion and days 1, 3 and 7
Sepsis-induced immuno-inflammatory responses
Time frame: Inclusion and days 1, 3 and 7
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 9 Oct 2026.
- Individual participant dataSharing planned: No
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.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Adult Patients With Septic Shock Admitted in Intensive Care Unit, run by Hospices Civils de Lyon at 23 sites in France.
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 6 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Martin COUR, MD (4 72 11 28 52 ext. +33, martin.cour@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at day 90 after inclusion (time frame: 90 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.