REmote Ischemic COnditioning in Septic Shock (RECO-Sepsis)

Civil Hospices of Lyon

Status: Completed

Conditions: Septic Shock

Treatments: Device: Remote Ischemic conditioning; Device: Patients with no remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03201575

69HCL17_0290

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Remote ischemic conditioning

Experimental group

Description:

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.

Treatment:

Device: Remote Ischemic conditioning

Control group

Other group

Description:

A brachial cuff is positioned around the arm of the patient. No inflation or deflation is made.

Treatment:

Device: Patients with no remote ischemic conditioning