Remote Ischemic Postconditioning in Septic Shock

NCT ID: NCT07273942

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2028-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote ischemic conditioning

Intervention Type: 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.

Control group

No intervention wil be performed in the control group.

Group Type: OTHER

No intervention

Intervention Type: OTHER

No intervention will be performed in the conrol group

Interventions

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.

Intervention Type: OTHER

No intervention

No intervention will be performed in the conrol group

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Besançon, , France

Service Réanimation Polyvalente, Centre Hospitalier de Fleyriat

Bourg-en-Bresse, , France

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

Clermont-Ferrand, , France

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

Créteil, , France

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

Dijon, , France

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

La Tronche, , France

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

Le Kremlin-Bicêtre, , France

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

Lille, , France

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

Lyon, , France

Service Réanimation Polyvalente, Hôpital Saint-Joseph Saint-Luc

Lyon, , France

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

Marseille, , France

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

Marseille, , France

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

Montpellier, , France

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

Nancy, , France

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

Nantes, , France

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

Paris, , France

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

Pierre-Bénite, , France

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

Reims, , France

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

Rennes, , France

Service Réanimation Polyvalente, Centre Hospitalier de Roanne

Roanne, , France

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

Saint-Priest-en-Jarez, , France

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

Strasbourg, , France

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

Tours, , France

Countries

France

Central Contacts

Martin COUR, MD

Role: CONTACT

martin.cour@chu-lyon.fr

4 72 11 28 52 ext. +33

Facility Contacts

Gaël PITON, MD

Role: primary

François DHELFT, MD

Role: primary

Maxime DUMESNIL, MD

Role: primary

Armand MEKONTSO-DESSAP, MD

Role: primary

Jean-Pierre QUENOT, MD

Role: primary

Carole SCHWEBEL, MD

Role: primary

Tai PHAM, MD

Role: primary

Raphaël FAVORY, MD

Role: primary

Martin COUR, MD

Role: primary

Emmanuel VIVIER, MD

Role: primary

Sami HRAIECH, MD

Role: primary

Marc GAINNIER, MD

Role: primary

Kada KLOUCHE, MD

Role: primary

Sébastien GIBOT, MD

Role: primary

Jean REIGNIER, MD

Role: primary

Jean-Paul MIRA, MD

Role: primary

Auguste DARGENT, MD

Role: primary

David BUSSY, MD

Role: primary

Félicie BELICARD, MD

Role: primary

Pascal BEURET, MD

Role: primary

Sophie PERINEL, MD

Role: primary

Hamid MERDJI, MD

Role: primary

Juliette POCQUET, MD

Role: primary

Other Identifiers

69HCL24_0937

Identifier Type: -

Identifier Source: org_study_id