External Cooling in Septic Shock Patients

Septic Shock Clinical Trial

— sepsis-cool  

Official title:

Impact of External Cooling in Septic Shock Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527007
• Other study ID #: SCR06012
• Status: Completed
• Phase: N/A
• First received: September 6, 2007
• Last updated: July 21, 2010
• Start date: October 2007
• Est. completion date: March 2010

Study information

• Verified date: August 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• External cooling
External cooling

Locations

Country	Name	City	State
France	CHU Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment		48 hours after enrolment	Yes
Secondary	Maximal dose of vasopressors		within 48 hours after enrolment	Yes
Secondary	SOFA score evolution		on Day 3, Day 7, Day 14	No
Secondary	Number of vasopressor free days in the ICU		during the study	Yes