Septic ShockRECO-SepsisNCT03201575
REmote Ischemic COnditioning in Septic Shock
A study testing Remote Ischemic conditioning and Patients with no remote ischemic conditioning in people with Septic Shock, run by Hospices Civils de Lyon at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Remote Ischemic conditioning and Patients with no remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesFrance
- Study dates
- 28 Nov 2017to 12 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Clermont-Ferrand
Clermont-Ferrand
CHU de Grenoble
Grenoble
Hôpital Edouard Herriot
Lyon
CHU de Montpellier
Montpellier
CH de Roanne
Roanne
CHU de Saint-Etienne
Saint-Etienne
About this study
Official title: REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study
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.
- Conditions
- Septic Shock
- Being tested
- Remote Ischemic conditioning, Patients with no remote ischemic conditioning
- Keywords
- Intensive care, septic shock, multiple organ failure, Ischemia-reperfusion, ischemic conditioning, remote conditioning, SOFA score
- Medical subject headings
- Shock, Septic, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic conditioningDevice
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 conditioningDevice
A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Experimental | 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. Receives: Device: Remote Ischemic conditioning |
| Control group | Other | A brachial cuff is positioned around the arm of the patient. No inflation or deflation is made. Receives: Device: Patients with no remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 96 hours.
Secondary outcomes (13)
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).
Measured: 96 hours.
SOFA score.
Measured: 24 hours
SOFA score.
Measured: 48 hours
SOFA score.
Measured: 72 hours
SOFA score.
Measured: 96 hours
Variations of SOFA score (delta-SOFA)
Measured: 24 hours
SOFA sub-scores for each organs
Measured: 48 hours
SOFA sub-scores for each organs
Measured: 72 hours
SOFA sub-scores for each organs
Measured: 96 hours
Survival without organ support
Measured: Day 28
Intensive care unit (ICU) length of stay.
Measured: Day 90
Hospital length of stay
Measured: Day 90
All-cause mortality
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start28 Nov 2017
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin COUR, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201575
- Sponsor's protocol ID
- 69HCL17_0290
- Acronym
- RECO-Sepsis
- Status last verified
- Nov 2025
- First submitted
- 26 Jun 2017
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cour M, Buisson M, Klouche K, Bouzgarrou R, Schwebel C, Quenot JP, Zeni F, Beuret P, Ovize M, Argaud L. Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial. Trials. 2019 May 22;20(1):281. doi: 10.1186/s13063-019-3406-4.
PubMed 31118101Cour M, Klouche K, Souweine B, Quenot JP, Schwebel C, Perinel S, Amaz C, Buisson M, Ovize M, Mewton N, Argaud L; RECO-Sepsis Trial Investigators. Remote ischemic conditioning in septic shock: the RECO-Sepsis randomized clinical trial. Intensive Care Med. 2022 Nov;48(11):1563-1572. doi: 10.1007/s00134-022-06872-1. Epub 2022 Sep 14.
PubMed 36100725
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study
- ClinicalTrials.gov ID
- NCT03201575
- Acronym / sponsor ID
- RECO-Sepsis / 69HCL17_0290
- Conditions
- Septic Shock
- Keywords
- Intensive care, septic shock, multiple organ failure, Ischemia-reperfusion, ischemic conditioning, remote conditioning, SOFA score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Experimental | Device: Remote Ischemic conditioningA brachial cuff is positioned around the arm of the patient. The remote ischemic conditioning consists in alternative inflations and deflations of the brachial cuff. |
| Control group | Other | Device: Patients with no remote ischemic conditioningA brachial cuff is positioned around the arm of the patient. No inflation or deflation is made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic conditioningA 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. | Device | Remote ischemic conditioning |
| Patients with no remote ischemic conditioningA brachial cuff is positioned around the arm of the patient and no inflation or deflation is made. | Device | Control group |
Primary outcome
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).
13 secondary outcomes
Average SOFA score without the neurologic sub-score.
Time frame: 96 hours.
SOFA score.
Time frame: 24 hours
SOFA score.
Time frame: 48 hours
SOFA score.
Time frame: 72 hours
SOFA score.
Time frame: 96 hours
Variations of SOFA score (delta-SOFA)
Time frame: 24 hours
SOFA sub-scores for each organs
Time frame: 48 hours
SOFA sub-scores for each organs
Time frame: 72 hours
SOFA sub-scores for each organs
Time frame: 96 hours
Survival without organ support
Time frame: Day 28
Intensive care unit (ICU) length of stay.
Time frame: Day 90
Hospital length of stay
Time frame: Day 90
All-cause mortality
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 31118101Cour M, Buisson M, Klouche K, Bouzgarrou R, Schwebel C, Quenot JP, Zeni F, Beuret P, Ovize M, Argaud L. Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial. Trials. 2019 May 22;20(1):281. doi: 10.1186/s13063-019-3406-4.
- Results publication: PubMed 36100725Cour M, Klouche K, Souweine B, Quenot JP, Schwebel C, Perinel S, Amaz C, Buisson M, Ovize M, Mewton N, Argaud L; RECO-Sepsis Trial Investigators. Remote ischemic conditioning in septic shock: the RECO-Sepsis randomized clinical trial. Intensive Care Med. 2022 Nov;48(11):1563-1572. doi: 10.1007/s00134-022-06872-1. Epub 2022 Sep 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin COUR principal investigator
Hospices Civils de Lyon
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic conditioning and Patients with no remote ischemic conditioning in people with Septic Shock, run by Hospices Civils de Lyon at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average SOFA score (Sequential Organ Failure Assessment) (time frame: 96 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03201575, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.