External Cooling in Septic Shock Patients

Study Overview
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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.

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.

Official Title
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Impact of External Cooling in Septic Shock Patients

Conditions
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Septic Shock

Intervention / Treatment
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* Other: External cooling


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Other: External cooling<br>* External cooling<br>|
| No Intervention: B<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment |  | 48 hours after enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vasopressor, Epinephrine, Norepinephrine, Cooling, Fever, ICU