Skip to main content
OpenTrials
Completed

NCT Number: NCT03201575

REmote Ischemic COnditioning in Septic Shock

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Septic Shock Infections Inflammation Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

remote ischemic conditioning

Device

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

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: RECO-Sepsis

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2017
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.