REmote Ischemic COnditioning in Septic Shock

NCT03201575 | Completed

• 1 other identifier: 69HCL17_0290
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 6

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.

Conditions

Septic Shock

Keywords

Intensive care; septic shock; multiple organ failure; Ischemia-reperfusion; ischemic conditioning; remote conditioning; SOFA score

Outcome Measures

Primary Outcomes (1)

• Average SOFA score (Sequential Organ Failure Assessment)

  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).

  96 hours.

Secondary Outcomes (13)

• Average SOFA score without the neurologic sub-score.

  96 hours.

• SOFA score.

  24 hours

• SOFA score.

  48 hours

• SOFA score.

  72 hours

• SOFA score.

  96 hours

Study Arms (2)

Remote ischemic conditioning

EXPERIMENTAL

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.

Device: Remote Ischemic conditioning

Control group

OTHER

A brachial cuff is positioned around the arm of the patient. No inflation or deflation is made.

Device: Patients with no remote ischemic conditioning

Interventions

Remote Ischemic conditioning DEVICE

A brachial cuff is positioned around the arm of the patient. Four cycles of \[5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation\] started as soon as possible after randomization. The intervention is repeated at 12 and 24 hours after inclusion.

Remote ischemic conditioning

Patients with no remote ischemic conditioning DEVICE

A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• Patients without health coverage

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (6)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU de Grenoble

Grenoble, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

CHU de Montpellier

Montpellier, France

Location

CH de Roanne

Roanne, France

Location

CHU de Saint-Etienne

Saint-Etienne, France

Location

Related Publications (2)

• Cour M, Buisson M, Klouche K, Bouzgarrou R, Schwebel C, Quenot JP, Zeni F, Beuret P, Ovize M, Argaud L. Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial. Trials. 2019 May 22;20(1):281. doi: 10.1186/s13063-019-3406-4.

  PMID: 31118101 RESULT

• Cour M, Klouche K, Souweine B, Quenot JP, Schwebel C, Perinel S, Amaz C, Buisson M, Ovize M, Mewton N, Argaud L; RECO-Sepsis Trial Investigators. Remote ischemic conditioning in septic shock: the RECO-Sepsis randomized clinical trial. Intensive Care Med. 2022 Nov;48(11):1563-1572. doi: 10.1007/s00134-022-06872-1. Epub 2022 Sep 14.

  PMID: 36100725 RESULT

MeSH Terms

Conditions

Shock, Septic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Martin COUR

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: November 28, 2017
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)