REmote Ischemic COnditioning in Septic Shock (RECO-Sepsis)

REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Device: Remote Ischemic conditioning; Device: Patients with no remote ischemic conditioning

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU de Clermont-Ferrand
  • Grenoble, France
    • CHU de Grenoble
  • Lyon, France
    • Hôpital Edouard Herriot
  • Montpellier, France
    • CHU de Montpellier
  • Roanne, France
    • CH de Roanne
  • Saint-Étienne, France
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Remote Ischemic conditioning; 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.
Other: Control group; A brachial cuff is positioned around the arm of the patient. No inflation or deflation is made.	Device: Patients with no remote ischemic conditioning; A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average SOFA score without the neurologic sub-score.	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).	96 hours.
SOFA score.		24 hours
SOFA score.		48 hours
SOFA score.		72 hours
SOFA score.		96 hours
Variations of SOFA score (delta-SOFA)		24 hours
SOFA sub-scores for each organs		48 hours
SOFA sub-scores for each organs		72 hours
SOFA sub-scores for each organs		96 hours
Survival without organ support		Day 28
Intensive care unit (ICU) length of stay.		Day 90
Hospital length of stay		Day 90
All-cause mortality		Day 90

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Martin COUR, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): August 12, 2019
• Study Completion (Actual): August 12, 2019

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: septic shock; Intensive care; SOFA score; multiple organ failure; Ischemia-reperfusion; ischemic conditioning; remote conditioning
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 69HCL17_0290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No