COrporeal Compression at the ONset of Severe Sepsis and Septic Shock (COCOON)

February 5, 2026 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: Whole-body compression

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Chalon-sur-Saône, France, 71321
    - CH Chalon sur Saone
  - Dijon, France, 21079
    - CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fluid balance Time Frame: At 7 days	At 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2015

Primary Completion (Actual)

March 27, 2017

Study Completion (Actual)

March 27, 2017

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimated)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

LARGE 2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.