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

Primary Purpose

Severe Sepsis or Septic Shock, Fluid Resuscitation

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Whole-body compression
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis or Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CH Chalon sur SaôneRecruiting
  • CHU de DIJONRecruiting

Outcomes

Primary Outcome Measures

Fluid balance

Secondary Outcome Measures

Full Information

First Posted
January 11, 2016
Last Updated
January 14, 2016
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02656654
Brief Title
COrporeal Compression at the ONset of Severe Sepsis and Septic Shock
Acronym
COCOON
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis or Septic Shock, Fluid Resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Whole-body compression
Primary Outcome Measure Information:
Title
Fluid balance
Time Frame
At 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Auguste DARGENT
Phone
03 80 29 52 43
Ext
+33
Email
auguste.dargent@chu-dijon.fr
Facility Information:
Facility Name
CH Chalon sur Saône
City
Chalon sur Saône
ZIP/Postal Code
71321
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc DOISE
Phone
03 85 91 02 85
Ext
+33
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Auguste DARGENT
Phone
03 80 29 52 43
Ext
+33
Email
auguste.dargent@chu-dijon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

COrporeal Compression at the ONset of Severe Sepsis and Septic Shock

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