Remote Ischemic Postconditioning in Septic Shock

NCT07273942 | Not Yet Recruiting DMC

• 1 other identifier: 69HCL24_0937
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 23

Brief 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. 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.

Conditions

Adult Patients With Septic Shock Admitted in Intensive Care Unit

Keywords

Septic shock; Remote conditioning; Ischemic conditioning; Ischemia-reperfusion; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at day 90 after inclusion

  90 days after inclusion

Secondary Outcomes (5)

• Functional recovery

  Day 90

• SF-36 (Short Form-36 Health Survey) questionnaire score

  Day 90

• Number of days alive without vasopressors

  Day 7

• Sepsis-related Organ Failure Assessment (SOFA) score

  Inclusion and days 1, 3 and 7

• Sepsis-induced immuno-inflammatory responses

  Inclusion and days 1, 3 and 7

Study Arms (2)

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.

Other: Remote ischemic conditioning

Control group

OTHER

No intervention wil be performed in the control group.

Other: No intervention

Interventions

Remote ischemic conditioning OTHER

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.

Remote ischemic conditioning

No intervention OTHER

No intervention will be performed in the conrol group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (23)

Service de Réanimation Médicale, Hôpital Jean-Minjoz, CHU de Besançon

Besançon, 25030, France

Location

Service Réanimation Polyvalente, Centre Hospitalier de Fleyriat

Bourg-en-Bresse, 01012, France

Location

Service de Médecine Intensive- Réanimation, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Service de Médecine Intensive-Réanimation, Hôpital Henri Mondor, Assistance Publique des Hôpitaux de Paris

Créteil, 94000, France

Location

Service de Médecine intensive-Réanimation,Hôpital F Mitterrand, CHU de Dijon

Dijon, 21079, France

Location

Service de Médecine intensive-Réanimation,Hôpital Albert Michallon, CHU de Grenoble

La Tronche, 38700, France

Location

Service de Médecine Intensive-Réanimation, Hôpital Bicêtre, Assistance Publique des Hôpitaux de Paris

Le Kremlin-Bicêtre, 94270, France

Location

Service de Médecine Intensive-Réanimation, Hôpital Salengro, CHU de Lille

Lille, 59037, France

Location

Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, 69003, France

Location

Service Réanimation Polyvalente, Hôpital Saint-Joseph Saint-Luc

Lyon, 69007, France

Location

Service de Médecine Intensive-Réanimation, Hôpital Nord, Assistance Publique des Hôpitaux de Marseille

Marseille, 13015, France

Location

Service de Réanimation des Urgences, Hôpital de la Timone, CHU de Marseille

Marseille, 13385, France

Location

Service de Médecine intensive-Réanimation, Hôpital Lapeyronie, CHU de Montpellier

Montpellier, 34295, France

Location

Service de Médecine Intensive-Réanimation, Hôpital Central, CHRU de Nancy

Nancy, 54035, France

Location

Service de Médecine Intensive-Réanimation, Hôtel Dieu, CHU de Nantes

Nantes, 44093, France

Location

Service de Médecine Intensive - Réanimation, Hôpital Cochin, Assistance Publique des Hôpitaux de Paris

Paris, 75014, France

Location

Service d'Anesthésie - Réanimation - Médecine Intensive, Hôpital Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Service de Médecine Intensive et Réanimation Polyvalente, Hôpital Robert Debré, CHU Reims

Reims, 51090, France

Location

Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes

Rennes, 35000, France

Location

Service Réanimation Polyvalente, Centre Hospitalier de Roanne

Roanne, 42328, France

Location

Service de Médecine intensive-Réanimation, Hôpital Nord, CHU de St Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Service de Médecine Intensive-Réanimation, Nouvel Hôpital Civil, CHU de Strasbourg

Strasbourg, 67091, France

Location

Service de Médecine Intensive-Réanimation, Hôpital Bretonneau, CHRU de Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Martin COUR, MD

CONTACT

4 72 11 28 52; martin.cour@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In the control group, no intervention is performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (23)