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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

720

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

April 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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