REmote Ischemic COnditioning in Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Device: Patients with no remote ischemic conditioning; Device: Remote Ischemic conditioning

• Registration Number: NCT03201575
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Septic shock remains a major public health problem in industrialized countries, with a mortality rate as high as 50%, largely related to multiple organ dysfunction. In addition to dysregulated inflammatory response, the pathophysiology of organ failures in septic shock involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy for protecting organs against the detrimental effects of ischemia-reperfusion injury.

The objective of the present study is to determine whether remote ischemic conditioning can limit the severity of organ failure in patients with septic shock.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Study Start: 2017-11-28
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Age ≥ 18 years
• Hospitalization in an intensive care unit for less than 24 hours
• Septic shock evolving for less than 12 hours defined as:
• Documented or suspected infection
• Norepinephrine administration to maintain a mean arterial pressure ≥ 65 mmHg after volemia correction
• Lactatemia > 2 mmol/L at least once in the past 12 hours before inclusion
• Written informed consent signed by the patient or by a next of kin or oral consent given by the patient and as soon as permitted by the clinical state written informed consent signed by the patient.

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Exclusion Criteria

• Patient who has expressed the wish not to be resuscitated
• Contraindication of the use of brachial cuff on both arms
• Intercurrent pathology with an expected life expectancy of less than 24 hours
• Cardiac arrest
• Female patients currently pregnant or women of childbearing age who are not using contraception
• Previous inclusion in RECO-Sepsis study
• Previous inclusion in another clinical study
• Patients without health coverage

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Patients with no remote ischemic conditioning	A brachial cuff is positioned around the arm of the patient. No inflation or deflation is made.
Remote ischemic conditioning	Remote Ischemic conditioning	A brachial cuff is positioned around the arm of the patient. The remote ischemic conditioning consists in alternative inflations and deflations of the brachial cuff.

Primary Outcome Measures

Name	Time	Method
Average SOFA score (Sequential Organ Failure Assessment)	96 hours.	The SOFA score ranges from 0 to 24 (higher scores indicate more severe organ failure), with 0 to 4 points assigned for each of 6 organ dysfunctions (ie, central nervous system, cardiovascular, respiratory, renal, coagulation, and liver).

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	Day 90
All-cause mortality	Day 90
Average SOFA score without the neurologic sub-score.	96 hours.	The SOFA score without the neurologic subscore ranges from 0 to 20 (higher scores indicate more severe organ failure), with 0 to 4 points assigned for each of 5 organ dysfunctions (ie, cardiovascular, respiratory, renal, coagulation, and liver).
SOFA score.	96 hours
Variations of SOFA score (delta-SOFA)	24 hours
SOFA sub-scores for each organs	96 hours
Survival without organ support	Day 28
Intensive care unit (ICU) length of stay.	Day 90

Trial Locations

Locations (6)

CHU de Grenoble; 🇫🇷 Grenoble, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

CH de Roanne; 🇫🇷 Roanne, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Montpellier; 🇫🇷 Montpellier, France

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France