Mild Therapeutic Hypothermia During Severe Sepsis

Study Overview
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Brief Summary
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Objectives: to evaluate the feasibility, the safety and the effects on physiological parameters of mild therapeutic hypothermia during septic shock. Design: a randomized, controlled, pilot physiological study. Setting: a 15-beds university-affiliated intensive care unit of a teaching Hospital. Patients: twenty ventilated and sedated adults patients with septic shock Intervention: Mild therapeutic hypothermia between 32 and 34°C during 36 consecutive hours using an external water cooling blanket.

Official Title
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Mild Therapeutic Hypothermia During Severe Sepsis

Conditions
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Sepsis

Intervention / Treatment
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* Procedure: Mild therapeutic hypothermia induction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18-yrs, sedation and mechanical ventilation for at least 48-hrs, the diagnosis of septic shock according to standard guidelines. Exclusion Criteria: bradycardia < 50 bpm, or any severe ventricular rhythm disturbances, pregnancy, need for emergent surgery or any other complementary exam involving patient transport within the sixth hours following inclusion, decision to withdraw or withhold life support, predictable death within six hours.

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: Mild therapeutic hypothermia<br>Sepsis treatment according to standard guidelines plus mild therapeutic hypothermia | Procedure: Mild therapeutic hypothermia induction<br>* Mild Therapeutic hypothermia was induced immediately after patient inclusion. Patients were cooled between 32 and 34°c (33 ± 1°C; 90 and 93°F) for 36 hours, using the automatic mode of an external water cooling blanket (Meditherm II®, Gaymar, Orchard Park, NY, USA). The machine constantly compares actual patient temperature (measured by a rectal probe) with the set point, and automatically adjusts the blanket water temperature so that the desired patient temperature is achieved. The target temperature was to be reached within eight hour following inclusion. Rewarming was only passive (blanket switched off), and paralytic agents were to be stopped when the body temperature reached back 36°C (97°F).<br>|
| No Intervention: Control<br>Sepsis treatment according to standard guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of hypothermia induction during sepsis |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic parameters evolution |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis,, septic shock,, therapeutic hypothermia