Remote Ischemic Postconditioning in Septic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote ischemic conditioning, No intervention.
- Who it may be relevant to
- Registry conditions: Adult Patients With Septic Shock Admitted in Intensive Care Unit. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- 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 No intervention
No intervention will be performed in the conrol group
Primary outcome measures
- All-cause mortality at day 90 after inclusion [Time frame: 90 days after inclusion]
Secondary outcome measures (5)
- Functional recovery [Time frame: Day 90]
- SF-36 (Short Form-36 Health Survey) questionnaire score [Time frame: Day 90]
- Number of days alive without vasopressors [Time frame: Day 7]
- Sepsis-related Organ Failure Assessment (SOFA) score [Time frame: Inclusion and days 1, 3 and 7]
- Sepsis-induced immuno-inflammatory responses [Time frame: Inclusion and days 1, 3 and 7]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 23 centers
- Service de Réanimation Médicale, Hôpital Jean-Minjoz, CHU de Besançon — Besançon
- Service Réanimation Polyvalente, Centre Hospitalier de Fleyriat — Bourg-en-Bresse
- Service de Médecine Intensive- Réanimation, Hôpital Gabriel Montpied, CHU de Clermont-Ferr — Clermont-Ferrand
- Service de Médecine Intensive-Réanimation, Hôpital Henri Mondor, Assistance Publique des H — Créteil
- Service de Médecine intensive-Réanimation,Hôpital F Mitterrand, CHU de Dijon — Dijon
- Service de Médecine intensive-Réanimation,Hôpital Albert Michallon, CHU de Grenoble — La Tronche
- Service de Médecine Intensive-Réanimation, Hôpital Bicêtre, Assistance Publique des Hôpita — Le Kremlin-Bicêtre
- Service de Médecine Intensive-Réanimation, Hôpital Salengro, CHU de Lille — Lille
- … and 15 more centers
Identifiers
NCT: NCT07273942 · 69HCL24_0937