Adult Patients With Septic Shock Admitted in Intensive Care Unit
Conditions
Keywords
Septic shock, Remote conditioning, Ischemic conditioning, Ischemia-reperfusion, Intensive care unit
Brief summary
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.
Interventions
OTHERRemote ischemic conditioning
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.
OTHERNo intervention
No intervention will be performed in the conrol group
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
In the control group, no intervention is performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Hospitalized in intensive care unit for less than 24 hours * Septic shock (Sepsis-3 definition) evolving for less than 18 hours * Preliminary written informed consent obtained from the patient or his/her close relative, or use of the emergency procedure in accordance with local regulations
Exclusion criteria
* Contraindication of the use of a brachial pressure cuff on both arms * Cardiac arrest * Pregnancy or breast feeding * Participation in another interventional study * Lack of French national health insurance coverage * Patient with any legal protection measure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at day 90 after inclusion | 90 days after inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional recovery | Day 90 | Number of days alive after discharge at home by day 90 |
| SF-36 (Short Form-36 Health Survey) questionnaire score | Day 90 | Quality of livre is evaluated by SF-36 (Short Form-36 Health Survey) questionnaire at day 90 |
| Number of days alive without vasopressors | Day 7 | — |
| Sepsis-related Organ Failure Assessment (SOFA) score | Inclusion and days 1, 3 and 7 | The severity of multiple organ failure assessed by the Sepsis-related Organ Failure Assessment (SOFA) score |
| Sepsis-induced immuno-inflammatory responses | Inclusion and days 1, 3 and 7 | Dosage of inflammation biomarkers * Neutrophils to lymphocytes ratio for all patients * In about 100 patients (from two centers) with a biological collection, markers of inflammatory/immune response (including cytokines, monocyte HLA-DR (Human Leukocyte Antigen) expression, immature neutrophils) |
Countries
France
Contacts
CONTACTMartin COUR, MD
Outcome results
None listed