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Clinical Trials/NCT02656654
NCT02656654
Completed
N/A

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

Centre Hospitalier Universitaire Dijon2 sites in 1 country64 target enrollmentApril 30, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Severe Sepsis or Septic Shock
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
64
Locations
2
Primary Endpoint
Fluid balance
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2015
End Date
March 27, 2017
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Fluid balance

Time Frame: At 7 days

Study Sites (2)

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