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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02656654
• Collaborator: (none)
• Enrollment: 47
• Locations: 2
• Duration (Months): 13
• Patients Per Site: 23.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis or Septic Shock; Fluid Resuscitation	Other: Whole-body compression	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 47 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: May 1, 2016
• Anticipated Study Completion Date: May 1, 2016

Outcome Measures

Primary Outcome Measures

1. Fluid balance [At 7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Chalon sur Saône	Chalon sur Saône		France	71321
2	CHU de DIJON	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT02656654
• Other Study ID Numbers: LARGE 2014
• First Posted: Jan 15, 2016
• Last Update Posted: Jan 15, 2016
• Last Verified: Apr 1, 2015

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Sepsis; Toxemia; Shock, Septic; Shock

Study Results

No Results Posted as of Jan 15, 2016