Septic Shock
Conditions
Keywords
Intensive care, septic shock, multiple organ failure, Ischemia-reperfusion, ischemic conditioning, remote conditioning, SOFA score
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.
Interventions
DEVICERemote 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.
DEVICEPatients with no remote ischemic conditioning
A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average SOFA score (Sequential Organ Failure Assessment) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOFA score. | 24 hours | — |
| Variations of SOFA score (delta-SOFA) | 24 hours | — |
| SOFA sub-scores for each organs | 48 hours | — |
| Average SOFA score without the neurologic sub-score. | 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). |
| Intensive care unit (ICU) length of stay. | Day 90 | — |
| Hospital length of stay | Day 90 | — |
| All-cause mortality | Day 90 | — |
| Survival without organ support | Day 28 | — |
Countries
France
Outcome results
None listed