REmote Ischemic COnditioning in Septic Shock (RECO-Sepsis)
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|ClinicalTrials.gov Identifier: NCT03201575|
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : April 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Device: Remote Ischemic conditioning Device: Patients with no remote ischemic conditioning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study|
|Actual Study Start Date :||November 28, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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.
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.
- Average SOFA score (Sequential Organ Failure Assessment) [ Time Frame: 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).
- Average SOFA score without the neurologic sub-score. [ Time Frame: 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. [ Time Frame: 24 hours ]
- SOFA score. [ Time Frame: 48 hours ]
- SOFA score. [ Time Frame: 72 hours ]
- SOFA score. [ Time Frame: 96 hours ]
- Variations of SOFA score (delta-SOFA) [ Time Frame: 24 hours ]
- SOFA sub-scores for each organs [ Time Frame: 48 hours ]
- SOFA sub-scores for each organs [ Time Frame: 72 hours ]
- SOFA sub-scores for each organs [ Time Frame: 96 hours ]
- Survival without organ support [ Time Frame: Day 28 ]
- Intensive care unit (ICU) length of stay. [ Time Frame: Day 90 ]
- Hospital length of stay [ Time Frame: Day 90 ]
- All-cause mortality [ Time Frame: Day 90 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201575
|Contact: Martin COUR||4 72 11 00 15 ext email@example.com|
|Contact: Claire JOSSAN||4 27 86 66 90 ext firstname.lastname@example.org|
|CHU de Clermont-Ferrand||Not yet recruiting|
|Contact: Bertrand SOUWEINE|
|CHU de Grenoble||Not yet recruiting|
|Contact: Carole SCHWEBEL|
|Hôpital Edouard Herriot||Recruiting|
|Contact: Martin COUR, MD|
|Principal Investigator: Martin COUR, MD|
|CHU de Montpellier||Not yet recruiting|
|Contact: Kada KLOUCHE|
|CH de Roanne||Not yet recruiting|
|Contact: Pascal BEURET|
|CHU de Saint-Etienne||Not yet recruiting|
|Contact: Sophie PERINEL RAGEY|
|Principal Investigator:||Martin COUR||Hospices Civils de Lyon|