Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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
Other Name: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Saliha DJANE, Department of Clinical Research of Development
ClinicalTrials.gov Identifier: NCT00527007     History of Changes
Other Study ID Numbers: SCR06012
Study First Received: September 6, 2007
Last Updated: July 21, 2010
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 25, 2014