COrporeal Compression at the ONset of Severe Sepsis and Septic Shock (COCOON)
|ClinicalTrials.gov Identifier: NCT02656654|
Recruitment Status : Unknown
Verified April 2015 by Centre Hospitalier Universitaire Dijon.
Recruitment status was: Recruiting
First Posted : January 15, 2016
Last Update Posted : January 15, 2016
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||April 2015|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2016|
- Fluid balance [ Time Frame: At 7 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656654
|Contact: Auguste DARGENT||03 80 29 52 43 ext +firstname.lastname@example.org|
|CH Chalon sur Saône||Recruiting|
|Chalon sur Saône, France, 71321|
|Contact: Jean-Marc DOISE 03 85 91 02 85 ext +33|
|CHU de DIJON||Recruiting|
|Dijon, France, 21079|
|Contact: Auguste DARGENT 03 80 29 52 43 ext +33 email@example.com|