NCT02656654

COrporeal Compression at the ONset of Severe Sepsis and Septic Shock

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Sepsis or Septic Shock
• Fluid Resuscitation

Interventions

Type	Name	Description
OTHER	Whole-body compression

Timeline

• Start date: 2015-04-30
• Primary completion: 2017-03-27
• Completion: 2017-03-27
• First posted: 2016-01-15
• Last updated: 2026-02-09

Locations

2 sites across 1 country: France