External Cooling in Septic Shock Patients (sepsis-cool)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00527007
First received: September 6, 2007
Last updated: July 21, 2010
Last verified: August 2008

September 6, 2007
July 21, 2010
October 2007
March 2010   (final data collection date for primary outcome measure)
Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment [ Time Frame: 48 hours after enrolment ] [ Designated as safety issue: Yes ]
Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment [ Time Frame: 48 hours after enrolment ]
Complete list of historical versions of study NCT00527007 on ClinicalTrials.gov Archive Site
  • Maximal dose of vasopressors [ Time Frame: within 48 hours after enrolment ] [ Designated as safety issue: Yes ]
  • SOFA score evolution [ Time Frame: on Day 3, Day 7, Day 14 ] [ Designated as safety issue: No ]
  • Number of vasopressor free days in the ICU [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • Maximal dose of vasopressors within Maximal dose of vasopressors within 48 hours after enrolment [ Time Frame: within 48 hours after enrolment ]
  • SOFA score evolution on D3, D7, D14 [ Time Frame: on D3, D7, D14 ]
  • Number of vasopressor free days in the ICU [ Time Frame: during the study ]
Not Provided
Not Provided
 
External Cooling in Septic Shock Patients
Impact of 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Septic Shock
Other: External cooling
External cooling
Other Name: external cooling
  • Experimental: A
    Intervention: Other: External cooling
  • No Intervention: B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00527007
SCR06012
No
Saliha DJANE, Department of Clinical Research of Development
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Frederique SCHORTGEN, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP