Remote Ischemic Postconditioning in Septic Shock (RIPOST-sepsis)

January 26, 2026 updated by: Hospices Civils de Lyon
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
720

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Besançon, France, 25030
        • Service de Réanimation Médicale, Hôpital Jean-Minjoz, CHU de Besançon
        • Contact:
          • Gaël PITON, MD
      • Bourg-en-Bresse, France, 01012
        • Service Réanimation Polyvalente, Centre Hospitalier de Fleyriat
        • Contact:
          • François DHELFT, MD
      • Clermont-Ferrand, France, 63003
        • Service de Médecine Intensive- Réanimation, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand
        • Contact:
          • Maxime DUMESNIL, MD
      • Créteil, France, 94000
        • Service de Médecine Intensive-Réanimation, Hôpital Henri Mondor, Assistance Publique des Hôpitaux de Paris
        • Contact:
          • Armand MEKONTSO-DESSAP, MD
      • Dijon, France, 21079
        • Service de Médecine intensive-Réanimation,Hôpital F Mitterrand, CHU de Dijon
        • Contact:
          • Jean-Pierre QUENOT, MD
      • La Tronche, France, 38700
        • Service de Médecine intensive-Réanimation,Hôpital Albert Michallon, CHU de Grenoble
        • Contact:
          • Carole SCHWEBEL, MD
      • Le Kremlin-Bicêtre, France, 94270
        • Service de Médecine Intensive-Réanimation, Hôpital Bicêtre, Assistance Publique des Hôpitaux de Paris
        • Contact:
          • Tai PHAM, MD
      • Lille, France, 59037
        • Service de Médecine Intensive-Réanimation, Hôpital Salengro, CHU de Lille
        • Contact:
          • Raphaël FAVORY, MD
      • Lyon, France, 69003
        • Service de Médecine Intensive-Réanimation, Hôpital Édouard Herriot, Hospices Civils de Lyon
        • Contact:
          • Martin COUR, MD
      • Lyon, France, 69007
        • Service Réanimation Polyvalente, Hôpital Saint-Joseph Saint-Luc
        • Contact:
          • Emmanuel VIVIER, MD
      • Marseille, France, 13015
        • Service de Médecine Intensive-Réanimation, Hôpital Nord, Assistance Publique des Hôpitaux de Marseille
        • Contact:
          • Sami HRAIECH, MD
      • Marseille, France, 13385
        • Service de Réanimation des Urgences, Hôpital de la Timone, CHU de Marseille
        • Contact:
          • Marc GAINNIER, MD
      • Montpellier, France, 34295
        • Service de Médecine intensive-Réanimation, Hôpital Lapeyronie, CHU de Montpellier
        • Contact:
          • Kada KLOUCHE, MD
      • Nancy, France, 54035
        • Service de Médecine Intensive-Réanimation, Hôpital Central, CHRU de Nancy
        • Contact:
          • Sébastien GIBOT, MD
      • Nantes, France, 44093
        • Service de Médecine Intensive-Réanimation, Hôtel Dieu, CHU de Nantes
        • Contact:
          • Jean REIGNIER, MD
      • Paris, France, 75014
        • Service de Médecine Intensive - Réanimation, Hôpital Cochin, Assistance Publique des Hôpitaux de Paris
        • Contact:
          • Jean-Paul MIRA, MD
      • Pierre-Bénite, France, 69495
        • Service d'Anesthésie - Réanimation - Médecine Intensive, Hôpital Lyon Sud, Hospices Civils de Lyon
        • Contact:
          • Auguste DARGENT, MD
      • Reims, France, 51090
        • Service de Médecine Intensive et Réanimation Polyvalente, Hôpital Robert Debré, CHU Reims
        • Contact:
          • David BUSSY, MD
      • Rennes, France, 35000
        • Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes
        • Contact:
          • Félicie BELICARD, MD
      • Roanne, France, 42328
        • Service Réanimation Polyvalente, Centre Hospitalier de Roanne
        • Contact:
          • Pascal BEURET, MD
      • Saint-Priest-en-Jarez, France, 42270
        • Service de Médecine intensive-Réanimation, Hôpital Nord, CHU de St Etienne
        • Contact:
          • Sophie PERINEL, MD
      • Strasbourg, France, 67091
        • Service de Médecine Intensive-Réanimation, Nouvel Hôpital Civil, CHU de Strasbourg
        • Contact:
          • Hamid MERDJI, MD
      • Tours, France, 37000
        • Service de Médecine Intensive-Réanimation, Hôpital Bretonneau, CHRU de Tours
        • Contact:
          • Juliette POCQUET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Remote ischemic conditioning
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.
Other: Remote ischemic conditioning
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.
Other: Control group
No intervention wil be performed in the control group.
Other: No intervention
No intervention will be performed in the conrol group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All-cause mortality at day 90 after inclusion
Time Frame: 90 days after inclusion
90 days after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sepsis-related Organ Failure Assessment (SOFA) score
Time Frame: Inclusion and days 1, 3 and 7
The severity of multiple organ failure assessed by the Sepsis-related Organ Failure Assessment (SOFA) score
Inclusion and days 1, 3 and 7
Functional recovery
Time Frame: Day 90
Number of days alive after discharge at home by day 90
Day 90
SF-36 (Short Form-36 Health Survey) questionnaire score
Time Frame: Day 90
Quality of livre is evaluated by SF-36 (Short Form-36 Health Survey) questionnaire at day 90
Day 90
Number of days alive without vasopressors
Time Frame: Day 7
Day 7
Sepsis-induced immuno-inflammatory responses
Time Frame: Inclusion and days 1, 3 and 7

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)
Inclusion and days 1, 3 and 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL24_0937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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