Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

REmote Ischemic COnditioning in Septic Shock (RECO-Sepsis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201575
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment Phase
Septic Shock Device: Remote Ischemic conditioning Device: Patients with no remote ischemic conditioning Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
Experimental: Remote ischemic conditioning
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.
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.

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




Primary Outcome Measures :
  1. Average SOFA score (Sequential Organ Failure Assessment) [ Time Frame: 96 hours. ]
    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).


Secondary Outcome Measures :
  1. Average SOFA score without the neurologic sub-score. [ Time Frame: 96 hours. ]
    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).

  2. SOFA score. [ Time Frame: 24 hours ]
  3. SOFA score. [ Time Frame: 48 hours ]
  4. SOFA score. [ Time Frame: 72 hours ]
  5. SOFA score. [ Time Frame: 96 hours ]
  6. Variations of SOFA score (delta-SOFA) [ Time Frame: 24 hours ]
  7. SOFA sub-scores for each organs [ Time Frame: 48 hours ]
  8. SOFA sub-scores for each organs [ Time Frame: 72 hours ]
  9. SOFA sub-scores for each organs [ Time Frame: 96 hours ]
  10. Survival without organ support [ Time Frame: Day 28 ]
  11. Intensive care unit (ICU) length of stay. [ Time Frame: Day 90 ]
  12. Hospital length of stay [ Time Frame: Day 90 ]
  13. All-cause mortality [ Time Frame: Day 90 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201575


Locations
Layout table for location information
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, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Martin COUR Hospices Civils de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03201575    
Other Study ID Numbers: 69HCL17_0290
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Intensive care
septic shock
multiple organ failure
Ischemia-reperfusion
ischemic conditioning
remote conditioning
SOFA score
Additional relevant MeSH terms:
Layout table for MeSH terms
Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation