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External Cooling in Septic Shock Patients (sepsis-cool)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527007
First Posted: September 10, 2007
Last Update Posted: July 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Septic Shock Other: External cooling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of External Cooling in Septic Shock Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment [ Time Frame: 48 hours after enrolment ]

Secondary Outcome Measures:
  • Maximal dose of vasopressors [ Time Frame: within 48 hours after enrolment ]
  • SOFA score evolution [ Time Frame: on Day 3, Day 7, Day 14 ]
  • Number of vasopressor free days in the ICU [ Time Frame: during the study ]

Enrollment: 200
Study Start Date: October 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Other: External cooling
External cooling
No Intervention: B

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527007


Locations
France
CHU Henri Mondor
Creteil, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Frederique SCHORTGEN, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Saliha DJANE, Department of Clinical Research of Development
ClinicalTrials.gov Identifier: NCT00527007     History of Changes
Other Study ID Numbers: SCR06012
First Submitted: September 6, 2007
First Posted: September 10, 2007
Last Update Posted: July 22, 2010
Last Verified: August 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Vasopressor
Epinephrine
Norepinephrine
Cooling
Fever
ICU

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation