Mild Therapeutic Hypothermia During Severe Sepsis
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|ClinicalTrials.gov Identifier: NCT01069146|
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : February 17, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Procedure: Mild therapeutic hypothermia induction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mild Therapeutic Hypothermia During Severe Sepsis|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
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
- feasibility of hypothermia induction during sepsis [ Time Frame: 48 hours ]
- hemodynamic parameters evolution [ Time Frame: 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069146
|Réanimation Médicale, CHU de la Cavale Blanche|
|Brest, France, 29609|