COrporeal Compression at the ONset of Severe Sepsis and Septic Shock

NCT02656654 | Completed

• 1 other identifier: LARGE 2014
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Severe Sepsis or Septic Shock; Fluid Resuscitation

Outcome Measures

Primary Outcomes (1)

• Fluid balance

  At 7 days

Interventions

Whole-body compression OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (2)

CH Chalon sur Saône

Chalon-sur-Saône, 71321, France

Location

CHU de DIJON

Dijon, 21079, France

Location

Related Publications (1)

• 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.

  PMID: 31399609 RESULT

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 15, 2016
• Study Start: April 30, 2015
• Primary Completion: March 27, 2017
• Study Completion: March 27, 2017
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)