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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
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 and no inflation or deflation is made.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU de Grenoble
Grenoble, France
Hôpital Edouard Herriot
Lyon, France
CHU de Montpellier
Montpellier, France
CH de Roanne
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).
Time frame: 96 hours.
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).
Time frame: 96 hours.
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
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Roanne, France
CHU de Saint-Etienne
Saint-Etienne, France
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