COrporeal Compression at the ONset of Severe Sepsis and Septic Shock

Fluid Resuscitation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656654
• Other study ID #: LARGE 2014
• Status: Completed
• Phase: N/A
• Start date: April 30, 2015
• Est. completion date: March 27, 2017

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 27, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Resuscitation
• Sepsis
• Severe Sepsis or Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

Other:
• Whole-body compression

Locations

Country	Name	City	State
France	CH Chalon sur Saône	Chalon sur Saône
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid balance		At 7 days