Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Septic shock is a leading cause of death worldwide despite intensive research efforts. Only a few interventions have been proven to be effective in improving patient-centered outcomes. Recent clinical trials have reported the safety and efficacy of remote ischemic postconditioning (RIPOST) in a variety of pathologies, including myocardial infarction, cardiac surgery, and stroke. While RIPOST was mainly tested in pathologies with low mortality rates, several follow-up studies of large randomized clinical trials in acute myocardial infarction and in patients undergoing coronary artery bypass surgery have reported significant decreases (> 50%) in long-term mortality. Experimental studies and proof-of-concept clinical trials have also suggested the potential benefits of RIPOST on mortality in sepsis and septic shock. The present protocol aims to test whether this non-invasive, widely available, inexpensive, and innovative intervention can improve survival in septic shock.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischemic conditioning | Experimental | A brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of alternating inflations and deflations of the brachial cuff. Four cycles of ischemic conditioning (5-min brachial cuff inflation at 200 mmHg followed by 5-min cuff deflation) are started as soon as possible after inclusion. The intervention is repeated 12 and 24 hours after inclusion. |
|
| Control group | Other | No intervention wil be performed in the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Other | A brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of alternating inflations and deflations of the brachial cuff. Four cycles of ischemic conditioning (5-min brachial cuff inflation at 200 mmHg followed by 5-min cuff deflation) are started as soon as possible after inclusion. The intervention is repeated 12 and 24 hours after inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality at day 90 after inclusion | 90 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Functional recovery | Number of days alive after discharge at home by day 90 | Day 90 |
| SF-36 (Short Form-36 Health Survey) questionnaire score | Quality of livre is evaluated by SF-36 (Short Form-36 Health Survey) questionnaire at day 90 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin COUR, MD | Contact | 4 72 11 28 52 | +33 | martin.cour@chu-lyon.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Réanimation Médicale, Hôpital Jean-Minjoz, CHU de Besançon | Besançon | 25030 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In the control group, no intervention is performed.
Not provided
|
| No intervention | Other | No intervention will be performed in the conrol group |
|
| Day 90 |
| Number of days alive without vasopressors | Day 7 |
| Sepsis-related Organ Failure Assessment (SOFA) score | The severity of multiple organ failure assessed by the Sepsis-related Organ Failure Assessment (SOFA) score | Inclusion and days 1, 3 and 7 |
| Sepsis-induced immuno-inflammatory responses | Dosage of inflammation biomarkers
| Inclusion and days 1, 3 and 7 |
| Service Réanimation Polyvalente, Centre Hospitalier de Fleyriat | Bourg-en-Bresse | 01012 | France |
|
| Service de Médecine Intensive- Réanimation, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
|
| Service de Médecine Intensive-Réanimation, Hôpital Henri Mondor, Assistance Publique des Hôpitaux de Paris | Créteil | 94000 | France |
|
| Service de Médecine intensive-Réanimation,Hôpital F Mitterrand, CHU de Dijon | Dijon | 21079 | France |
|
| Service de Médecine intensive-Réanimation,Hôpital Albert Michallon, CHU de Grenoble | La Tronche | 38700 | France |
|
| Service de Médecine Intensive-Réanimation, Hôpital Bicêtre, Assistance Publique des Hôpitaux de Paris | Le Kremlin-Bicêtre | 94270 | France |
|
| Service de Médecine Intensive-Réanimation, Hôpital Salengro, CHU de Lille | Lille | 59037 | France |
|
| Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot, Hospices Civils de Lyon | Lyon | 69003 | France |
|
| Service Réanimation Polyvalente, Hôpital Saint-Joseph Saint-Luc | Lyon | 69007 | France |
|
| Service de Médecine Intensive-Réanimation, Hôpital Nord, Assistance Publique des Hôpitaux de Marseille | Marseille | 13015 | France |
|
| Service de Réanimation des Urgences, Hôpital de la Timone, CHU de Marseille | Marseille | 13385 | France |
|
| Service de Médecine intensive-Réanimation, Hôpital Lapeyronie, CHU de Montpellier | Montpellier | 34295 | France |
|
| Service de Médecine Intensive-Réanimation, Hôpital Central, CHRU de Nancy | Nancy | 54035 | France |
|
| Service de Médecine Intensive-Réanimation, Hôtel Dieu, CHU de Nantes | Nantes | 44093 | France |
|
| Service de Médecine Intensive - Réanimation, Hôpital Cochin, Assistance Publique des Hôpitaux de Paris | Paris | 75014 | France |
|
| Service d'Anesthésie - Réanimation - Médecine Intensive, Hôpital Lyon Sud, Hospices Civils de Lyon | Pierre-Bénite | 69495 | France |
|
| Service de Médecine Intensive et Réanimation Polyvalente, Hôpital Robert Debré, CHU Reims | Reims | 51090 | France |
|
| Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes | Rennes | 35000 | France |
|
| Service Réanimation Polyvalente, Centre Hospitalier de Roanne | Roanne | 42328 | France |
|
| Service de Médecine intensive-Réanimation, Hôpital Nord, CHU de St Etienne | Saint-Priest-en-Jarez | 42270 | France |
|
| Service de Médecine Intensive-Réanimation, Nouvel Hôpital Civil, CHU de Strasbourg | Strasbourg | 67091 | France |
|
| Service de Médecine Intensive-Réanimation, Hôpital Bretonneau, CHRU de Tours | Tours | 37000 | France |
|
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
Not provided
Not provided