REmote Ischemic COnditioning in Septic Shock

Septic Shock Clinical Trial

— RECO-Sepsis  

Official title:

REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201575
• Other study ID #: 69HCL17_0290
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: August 12, 2019

Study information

• Verified date: July 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• Remote Ischemic conditioning
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.
• Patients with no remote ischemic conditioning
A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CHU de Grenoble	Grenoble
France	Hôpital Edouard Herriot	Lyon
France	CHU de Montpellier	Montpellier
France	CH de Roanne	Roanne
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	SOFA score.		24 hours
Secondary	SOFA score.		48 hours
Secondary	SOFA score.		72 hours
Secondary	SOFA score.		96 hours
Secondary	Variations of SOFA score (delta-SOFA)		24 hours
Secondary	SOFA sub-scores for each organs		48 hours
Secondary	SOFA sub-scores for each organs		72 hours
Secondary	SOFA sub-scores for each organs		96 hours
Secondary	Survival without organ support		Day 28
Secondary	Intensive care unit (ICU) length of stay.		Day 90
Secondary	Hospital length of stay		Day 90
Secondary	All-cause mortality		Day 90