External Cooling in Septic Shock Patients

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Other: External cooling

• Registration Number: NCT00527007
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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.

Study Timeline

• Study First Submitted: 2007-09-06
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Study Start: 2007-10
• Status Verified: 2008-08
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-07-21
• Last Update Posted: 2010-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	External cooling	-

Primary Outcome Measures

Name	Time	Method
Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment	48 hours after enrolment

Secondary Outcome Measures

Name	Time	Method
Maximal dose of vasopressors	within 48 hours after enrolment
SOFA score evolution	on Day 3, Day 7, Day 14
Number of vasopressor free days in the ICU	during the study

Trial Locations

Locations (1)

CHU Henri Mondor; 🇫🇷 Creteil, France