Remote Ischemic Postconditioning in Septic Shock (RIPOST-sepsis)

Civil Hospices of Lyon

Status: Begins enrollment in 1 month

Conditions: Adult Patients With Septic Shock Admitted in Intensive Care Unit

Treatments: Other: Remote ischemic conditioning; Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07273942

69HCL24_0937

Details and patient eligibility

About

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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 2 patient groups

Remote ischemic conditioning

Experimental group

Description:

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.

Treatment:

Other: Remote ischemic conditioning

Control group

Other group

Description:

No intervention wil be performed in the control group.

Treatment:

Other: No intervention