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REmote Ischemic COnditioning in Septic Shock (RECO-Sepsis)

Primary Purpose

Septic Shock

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Remote Ischemic conditioning
Patients with no remote ischemic conditioning
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Intensive care, septic shock, multiple organ failure, Ischemia-reperfusion, ischemic conditioning, remote conditioning, SOFA score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-Ferrand
  • CHU de Grenoble
  • Hôpital Edouard Herriot
  • CHU de Montpellier
  • CH de Roanne
  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Remote ischemic conditioning

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
SOFA score.
SOFA score.
SOFA score.
SOFA score.
Variations of SOFA score (delta-SOFA)
SOFA sub-scores for each organs
SOFA sub-scores for each organs
SOFA sub-scores for each organs
Survival without organ support
Intensive care unit (ICU) length of stay.
Hospital length of stay
All-cause mortality

Full Information

First Posted
June 26, 2017
Last Updated
July 25, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03201575
Brief Title
REmote Ischemic COnditioning in Septic Shock
Acronym
RECO-Sepsis
Official Title
REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
August 12, 2019 (Actual)
Study Completion Date
August 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Intensive care, septic shock, multiple organ failure, Ischemia-reperfusion, ischemic conditioning, remote conditioning, SOFA score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic conditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
A brachial cuff is positioned around the arm of the patient. No inflation or deflation is made.
Intervention Type
Device
Intervention Name(s)
Remote Ischemic conditioning
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Patients with no remote ischemic conditioning
Intervention Description
A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made.
Primary Outcome Measure Information:
Title
Average SOFA score (Sequential Organ Failure Assessment)
Description
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).
Time Frame
96 hours.
Secondary Outcome Measure Information:
Title
Average SOFA score without the neurologic sub-score.
Description
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).
Time Frame
96 hours.
Title
SOFA score.
Time Frame
24 hours
Title
SOFA score.
Time Frame
48 hours
Title
SOFA score.
Time Frame
72 hours
Title
SOFA score.
Time Frame
96 hours
Title
Variations of SOFA score (delta-SOFA)
Time Frame
24 hours
Title
SOFA sub-scores for each organs
Time Frame
48 hours
Title
SOFA sub-scores for each organs
Time Frame
72 hours
Title
SOFA sub-scores for each organs
Time Frame
96 hours
Title
Survival without organ support
Time Frame
Day 28
Title
Intensive care unit (ICU) length of stay.
Time Frame
Day 90
Title
Hospital length of stay
Time Frame
Day 90
Title
All-cause mortality
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin COUR
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Name
CH de Roanne
City
Roanne
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36100725
Citation
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.
Results Reference
derived
PubMed Identifier
31118101
Citation
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.
Results Reference
derived

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REmote Ischemic COnditioning in Septic Shock

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