REmote COnditioning in Out-of-Hospital Cardiac Arrest
ConditionOut-Of-Hospital Cardiac Arrest
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospices Civils de Lyon
About this trial
Out-of-Hospital Cardiac Arrest remains a major public health problem, resulting in high mortality largely related to multiple organ failure and poor neurological outcomes due to brain anoxia. The pathophysiology of organ dysfunction after resuscitated out-of-hospital cardiac arrest involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy used to protect organs against the detrimental effects of ischemia-reperfusion injury.
The objective of the present trial is to determine whether remote ischemic conditioning performed early after out-of-hospital cardiac arrest can decrease mortality, or multiple organ failure and/or severe neurological failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years old
Out-of-hospital cardiac arrest, whatever the initial cardiac rhythm (shockable or non-shockable) or the duration of no-flow and low-flow,
Presence of a witness who may or may not have started cardiopulmonary resuscitation, or patient seen alive in the 30 minutes prior to the cardiac arrest,
Hospitalisation in critical care (intensive care unit or cardiac intensive care unit) for less than 3 hours,
Disqualifiers
Traumatic cardiac arrest
Patient on extracorporeal circulatory assistance
Cardiac arrest for which continuation of resuscitation does not appear justified (unavoidable death, terminal stage of an irreversible disease, etc.)
Contraindication of the use of brachial cuff on both arms (arteriovenous fistula, lymphoedema or severe peripheral vascular pathology, unstable humeral fracture, continuous infusion into an upper limb vein of an essential drug such as a catecholamine, radial arterial catheter for continuous invasive measurement of blood pressure)
Trial design
Design model
Parallel
Treatments tested in this trial
Remote ischemic conditioning
DeviceA brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of four cycles of a 5-min brachial cuff inflation at 200 mmHg followed by a 5-min of cuff deflation, and is started as soon as possible after randomization. The intervention is repeated 12 and 24 hours after inclusion.
No remote ischemic conditioning
DeviceA brachial cuff is positioned around the arm of the patient and no inflation or deflation is performed.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Remote ischemic conditioningExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
All cause of death
All-cause death will be assessed 72 hours after hospital admission.
Time frame
72 hours after hospital admission2
Multiple organ failure
Multiple organ failure is defined by a SOFA (Sepsis-related Organ Failure Assessment) score, censored for the neurological component, greater than or equal to 5.
Time frame
72 hours after hospital admission3
Severe neurological failure
Severe neurological failure is defined by a motor component of the Glasgow Coma Score less than or equal to 3, without confounding factors (hypothermia less than or equal to 35.0°C, and/or sedation/analgesia/curarization). The glasgow coma score ranges from 3 to 15 and is broken down into its three parameters: eye opening, verbal response and motor response. The higher the score, the better the patient's recovery.
Time frame
72 hours after hospital admissionSecondary outcomes
1
Sepsis-related Organ Failure Assessment (SOFA) score
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
24 hours after hospital admission2
Sepsis-related Organ Failure Assessment (SOFA) score
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
48 hours after hospital admission3
Sepsis-related Organ Failure Assessment (SOFA) score
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
72 hours after hospital admission4
Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score
Time frame
24 hours after hospital admissionSponsors and contacts
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Source ClinicalTrials.gov