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NCT Number: NCT07273942

Remote Ischemic Postconditioning in Septic Shock

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.

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Key information

Conditions

Adult Patients With Septic Shock Admitted in Intensive Care Unit Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

No intervention

Other

No intervention will be performed in the conrol group

Primary outcomes

  1. All-cause mortality at day 90 after inclusion

    Time frame: 90 days after inclusion

Secondary outcomes

  1. Functional recovery

    Time frame: Day 90

    Number of days alive after discharge at home by day 90

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

    Time frame: Day 90

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

  3. Number of days alive without vasopressors

    Time frame: Day 7

  4. Sepsis-related Organ Failure Assessment (SOFA) score

    Time frame: Inclusion and days 1, 3 and 7

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

  5. Sepsis-induced immuno-inflammatory responses

    Time frame: Inclusion and days 1, 3 and 7

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Martin COUR, MD

CONTACT

[email protected]

4 72 11 28 52 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: RIPOST-sepsis

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 10, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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