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OpenTrials
Completed

NCT Number: NCT00527007

External Cooling in Septic Shock Patients

The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Henri Mondor

Créteil, 94000, France

About this study

Patients suffering from septic shock need fluid resuscitation and vasopressor therapy for restoring cardiovascular function. Corticosteroids and activated protein C have been both proposed for vascular tone improvement. While external cooling is largely used in ICU febrile patients, benefits and risks of fever treatment during sepsis have been rarely studied. Surveys show that external cooling is usual care applied by nurses themselves without medical order.

The control of thermal balance might decrease cardiac output and oxygen consumption, and reduce serum lactate concentration. However some animal studies have suggested that fever might be essential for host defence. This trial compares two strategies of fever management on vasopressor dependence in septic shock patients. In the treatment group, external cooling is applied to normalize the body temperature between 36°5 C and 37°C, while control patients receive any fever treatment. The goal for mean arterial pressure is the same in the two groups and vasopressor withdrawal is determined by similar algorithm.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented or suspected infection
  • Body temperature > 38.3°C
  • Persistent hypotension despite fluid resuscitation and need for vasopressor infusion to maintain mean arterial pressure > 65 mmHg.
  • Invasive mechanical ventilation
  • Intravenous sedation

Exclusion criteria

  • Temperature > 41°C
  • Age < 18 years
  • Pregnancy
  • Continuous renal replacement therapy
  • Paracetamol or NSAI administration within 6 hours before inclusion
  • Need for paracetamol and/or NSAI therapy during the study period
  • Burns or Lyell syndrome

Treatment and study plan

External cooling

Other

External cooling

Primary outcomes

  1. Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment

    Time frame: 48 hours after enrolment

Secondary outcomes

  1. Maximal dose of vasopressors

    Time frame: within 48 hours after enrolment

  2. SOFA score evolution

    Time frame: on Day 3, Day 7, Day 14

  3. Number of vasopressor free days in the ICU

    Time frame: during the study

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Impact of External Cooling in Septic Shock Patients

Acronym: sepsis-cool

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2007
Registry last updated
Jul 22, 2010

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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