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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischemic conditioning | Experimental | 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. |
|
| Control group | Other | A brachial cuff is positioned around the arm of the patient. No inflation or deflation is made. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic conditioning | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 96 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 96 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin COUR | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | France | ||||
| CHU de Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31118101 | Result | 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. | |
| 36100725 | Result | 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. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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|
| Patients with no remote ischemic conditioning | Device | A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made. |
|
| SOFA score. |
| 24 hours |
| SOFA score. | 48 hours |
| SOFA score. | 72 hours |
| SOFA score. | 96 hours |
| Variations of SOFA score (delta-SOFA) | 24 hours |
| SOFA sub-scores for each organs | 48 hours |
| SOFA sub-scores for each organs | 72 hours |
| SOFA sub-scores for each organs | 96 hours |
| Survival without organ support | Day 28 |
| Intensive care unit (ICU) length of stay. | Day 90 |
| Hospital length of stay | Day 90 |
| All-cause mortality | Day 90 |
| Grenoble |
| France |
| Hôpital Edouard Herriot | Lyon | France |
| CHU de Montpellier | Montpellier | France |
| CH de Roanne | Roanne | France |
| CHU de Saint-Etienne | Saint-Etienne | France |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |