External Cooling in Septic Shock Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

External cooling

Intervention Type OTHER

External cooling

B

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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External cooling

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No