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Remote Ischemic Postconditioning in Septic Shock

ConditionAdult Patients With Septic Shock Admitted in Intensive Care Unit
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindication of the use of a brachial pressure cuff on both arms

Cardiac arrest

Pregnancy or breast feeding

Participation in another interventional study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote ischemic conditioning

    Other intervention

    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 intervention

    No intervention will be performed in the conrol group

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: Remote ischemic conditioningExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality at day 90 after inclusion

Time frame
90 days after inclusion

Secondary outcomes

1

Functional recovery

Number of days alive after discharge at home by day 90

Time frame
Day 90
2

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
3

Number of days alive without vasopressors

Time frame
Day 7
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: