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CompletedNCT02656654COCOONUpdated Feb 9, 2026

COrporeal Compression at the ONset of Severe Sepsis and Septic Shock

An interventional study of Whole-body compression in Severe Sepsis or Septic Shock and Fluid Resuscitation, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2015, registered Jan 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Severe Sepsis or Septic Shock
  • Fluid Resuscitation
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 64 is below the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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,

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Interventions

  • OtherWhole-body compression
06

What researchers measure

Primary outcomes

  1. Fluid balance

    Time frame: At 7 days

07

Study locations

2 sites
  • CH Chalon sur Saône
    Chalon-sur-Saône, 71321, France
  • CHU de DIJON
    Dijon, 21079, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02656654
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Jan 15, 2016
Start date
Apr 30, 2015
Primary completion
Mar 27, 2017
Completion
Mar 27, 2017
Last update
Feb 9, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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