Severe Sepsis or Septic ShockCOCOONNCT02656654
COrporeal Compression at the ONset of Severe Sepsis and Septic Shock
A study testing Whole-body compression in people with Severe Sepsis or Septic Shock and Fluid Resuscitation, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
Early and adequate fluid resuscitation (< 6 hours) in patients with circulatory failure is essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably in patients with acute renal failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis or Septic Shock, Fluid Resuscitation
- What is being tested?
- Whole-body compression
- How many people
- 64 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Apr 2015to 27 Mar 2017
- 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
- Written informed consent from a person of trust,
- Patients aged 18 years or over,
- Admitted to a Medical ICU for less than 24 hours,
- For severe sepsis or septic shock and requiring fluid resuscitation because of hypotension and/or persistent signs of circulatory shock,
- On mechanical ventilation with orotracheal intubation,
Who cannot join
- Person not covered by national health insurance
- Recent abdominal or pelvic surgery,
- Contra-indication for a body bandage (PAD, Compartment Syndrome, acute rhabdomyolysis, wounds),
- Pregnant women,
- Patients with severe sepsis or septic shock for more than 24 hours,
- Patients who are moribund or in whom death is probably imminent (within 24h),
- Patients who have given instructions not to be resuscitated,
- Patients under ward of court.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH Chalon sur Saône
Chalon-sur-Saône, 71321
CHU de DIJON
Dijon, 21079
About this study
Official title: Pilot Study to Evaluate the Efficacy of and the Tolerance to a Body Bandage to Maintain Fluid Balance in Patients With Severe Sepsis or in Septic Shock in an ICU
Early and adequate fluid resuscitation (< 6 hours) in patients with circulatory failure is essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably in patients with acute renal failure. Improving fluid balance is considered crucial in the management of patients in septic shock, but the efficacy of the measures currently proposed (diuretics associated or not with albumin and/or dialysis) is controversial. The investigators hypothesize that a whole-body compression using a body bandage could reduce capillary leakage and thus lead to faster restoration of a normal transmural pressure gradient in postcapillary venules and improve venous return.
This is the first study to evaluate mechanical compression using a body bandage to reduce oedema in septic shock.
To do this, a whole-body compression will be set up within the 12 hours following admission. Water balance will be monitored daily throughout the duration of the compression and vital status of patients will be search at 7 days, 28 days and 90 days.
- Conditions
- Severe Sepsis or Septic Shock, Fluid Resuscitation
- Being tested
- Whole-body compression
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body compressionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid balance
Measured: At 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start30 Apr 2015
- Primary completion27 Mar 2017
- Study completion27 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Sepsis or Septic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656654
- Sponsor's protocol ID
- LARGE 2014
- Acronym
- COCOON
- Status last verified
- Feb 2026
- First submitted
- 11 Jan 2016
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dargent A, Large A, Soudry-Faure A, Doise JM, Abdulmalak C, Jonval L, Andreu P, Roudaut JB, Prin S, Charles PE, Payen D, Quenot JP; COCOONs study group. Corporeal Compression at the Onset of Septic shock (COCOONs): a compression method to reduce fluid balance of septic shock patients. Sci Rep. 2019 Aug 9;9(1):11566. doi: 10.1038/s41598-019-47939-2.
PubMed 31399609
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Efficacy of and the Tolerance to a Body Bandage to Maintain Fluid Balance in Patients With Severe Sepsis or in Septic Shock in an ICU
- ClinicalTrials.gov ID
- NCT02656654
- Acronym / sponsor ID
- COCOON / LARGE 2014
- Conditions
- Severe Sepsis or Septic Shock, Fluid Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 15 Jan 2016 (estimated)
- 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.
Early and adequate fluid resuscitation (< 6 hours) in patients with circulatory failure is essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably in patients with acute renal failure. Improving fluid balance is considered crucial in the management of patients in septic shock, but the efficacy of the measures currently proposed (diuretics associated or not with albumin and/or dialysis) is controversial. The investigators hypothesize that a whole-body compression using a body bandage could reduce capillary leakage and thus lead to faster restoration of a normal transmural pressure gradient in postcapillary venules and improve venous return.
This is the first study to evaluate mechanical compression using a body bandage to reduce oedema in septic shock.
To do this, a whole-body compression will be set up within the 12 hours following admission. Water balance will be monitored daily throughout the duration of the compression and vital status of patients will be search at 7 days, 28 days and 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent from a person of trust,
- Patients aged 18 years or over,
- Admitted to a Medical ICU for less than 24 hours,
- For severe sepsis or septic shock and requiring fluid resuscitation because of hypotension and/or persistent signs of circulatory shock,
- On mechanical ventilation with orotracheal intubation,
Key exclusion criteria (8 listed)
- Person not covered by national health insurance
- Recent abdominal or pelvic surgery,
- Contra-indication for a body bandage (PAD, Compartment Syndrome, acute rhabdomyolysis, wounds),
- Pregnant women,
- Patients with severe sepsis or septic shock for more than 24 hours,
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 |
|---|---|---|
| Whole-body compression | Other | – |
Primary outcome
Fluid balance
Time frame: At 7 days
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 9 Feb 2026.
- Results publication: PubMed 31399609Dargent A, Large A, Soudry-Faure A, Doise JM, Abdulmalak C, Jonval L, Andreu P, Roudaut JB, Prin S, Charles PE, Payen D, Quenot JP; COCOONs study group. Corporeal Compression at the Onset of Septic shock (COCOONs): a compression method to reduce fluid balance of septic shock patients. Sci Rep. 2019 Aug 9;9(1):11566. doi: 10.1038/s41598-019-47939-2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body compression in people with Severe Sepsis or Septic Shock and Fluid Resuscitation, run by Centre Hospitalier Universitaire Dijon at 2 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 5 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Fluid balance (time frame: At 7 days). 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 NCT02656654, which also lists 1 linked publication.
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 9 Feb 2026.