Remote Ischemic Postconditioning in Septic Shock

N/ANot Yet RecruitingNCT07273942

Hospices Civils de Lyon720 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

720

Conditions

Adult Patients With Septic Shock Admitted in Intensive Care Unit

Interventions

Remote ischemic conditioningOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

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

Outcomes

Primary Outcomes

All-cause mortality at day 90 after inclusion

Time frame: 90 days after inclusion

Secondary Outcomes

Functional recovery

Number of days alive after discharge at home by day 90

Time frame: Day 90

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

Quality of livre is evaluated by SF-36 (Short Form-36 Health Survey) questionnaire at day 90

Time frame: Day 90

Number of days alive without vasopressors

Time frame: Day 7

Sepsis-related Organ Failure Assessment (SOFA) score

The severity of multiple organ failure assessed by the Sepsis-related Organ Failure Assessment (SOFA) score

Time frame: Inclusion and days 1, 3 and 7

Sepsis-induced immuno-inflammatory responses

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)