Clinical trial NCT03201575: REmote Ischemic COnditioning in Septic Shock
Official title: REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: Intensive care
septic shock
multiple organ failure
Ischemia-reperfusion
ischemic conditioning
remote conditioning
SOFA score
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Average SOFA score (Sequential Organ Failure Assessment)
timeFrame: 96 hours.
Secondary outcomes:
measure: Average SOFA score without the neurologic sub-score.
timeFrame: 96 hours.
measure: SOFA score.
timeFrame: 24 hours
measure: SOFA score.
timeFrame: 48 hours
measure: SOFA score.
timeFrame: 72 hours
measure: SOFA score.
timeFrame: 96 hours
measure: Variations of SOFA score (delta-SOFA)
timeFrame: 24 hours
measure: SOFA sub-scores for each organs
timeFrame: 48 hours
measure: SOFA sub-scores for each organs
timeFrame: 72 hours
measure: SOFA sub-scores for each organs
timeFrame: 96 hours
measure: Survival without organ support
timeFrame: Day 28
measure: Intensive care unit (ICU) length of stay.
timeFrame: Day 90
measure: Hospital length of stay
timeFrame: Day 90
measure: All-cause mortality
timeFrame: Day 90
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Montpellier
country: France
facility: CHU de Montpellier
city: Roanne
country: France
facility: CH de Roanne
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Martin COUR
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.