Mild Therapeutic Hypothermia During Severe Sepsis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mild Therapeutic Hypothermia During Severe Sepsis|
- feasibility of hypothermia induction during sepsis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- hemodynamic parameters evolution [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||January 2002|
|Study Completion Date:||January 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
Experimental: Mild therapeutic hypothermia
Sepsis treatment according to standard guidelines plus mild therapeutic hypothermia
Procedure: Mild therapeutic hypothermia induction
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).
No Intervention: Control
Sepsis treatment according to standard guidelines
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069146
|Réanimation Médicale, CHU de la Cavale Blanche|
|Brest, France, 29609|