COrporeal Compression at the ONset of Severe Sepsis and Septic Shock

Not Applicable

Completed

• Conditions: Severe Sepsis or Septic Shock; Fluid Resuscitation

• Registration Number: NCT02656654
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-30
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-15
• Primary Completion: 2017-03-27
• Study Completion: 2017-03-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fluid balance	At 7 days

Trial Locations

Locations (2)

CH Chalon sur Saône; 🇫🇷 Chalon sur Saône, France

CHU de DIJON; 🇫🇷 Dijon, France