Mild Therapeutic Hypothermia During Severe Sepsis

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT01069146

First received: February 13, 2010

Last updated: February 16, 2010

Last verified: February 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	February 13, 2010
Last Updated Date	February 16, 2010
Start Date ^ICMJE	January 2002
Primary Completion Date	January 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 16, 2010)	feasibility of hypothermia induction during sepsis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01069146 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 16, 2010)	hemodynamic parameters evolution [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Mild Therapeutic Hypothermia During Severe Sepsis
Official Title ^ICMJE	Mild Therapeutic Hypothermia During Severe Sepsis
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Sepsis
Intervention ^ICMJE	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).
Study Arm (s)	Experimental: Mild therapeutic hypothermia Sepsis treatment according to standard guidelines plus mild therapeutic hypothermia Intervention: Procedure: Mild therapeutic hypothermia induction No Intervention: Control Sepsis treatment according to standard guidelines
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	January 2005
Primary Completion Date	January 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01069146
Other Study ID Numbers ^ICMJE	Hymosh
Has Data Monitoring Committee	Yes
Responsible Party	Pr Erwan L'HER, MD, PhD, CHU Brest
Study Sponsor ^ICMJE	University Hospital, Brest
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Brest
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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