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Completed

NCT Number: NCT02656654

COrporeal Compression at the ONset of Severe Sepsis and Septic Shock

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.

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Key information

Conditions

Severe Sepsis or Septic Shock Fluid Resuscitation Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Chalon sur Saône, Chalon-sur-Saône, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole-body compression

Other

Primary outcomes

  1. Fluid balance

    Time frame: At 7 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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

Acronym: COCOON

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2016
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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