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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201575
|Contact: Martin COUR||4 72 11 00 15 ext firstname.lastname@example.org|
|Contact: Claire JOSSAN||4 27 86 66 90 ext email@example.com|
|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|