Mild Therapeutic Hypothermia During Severe Sepsis
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable sepsis
Started Jan 2002
Typical duration for not_applicable sepsis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 13, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedFebruary 17, 2010
February 1, 2010
3 years
February 13, 2010
February 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
feasibility of hypothermia induction during sepsis
48 hours
Secondary Outcomes (1)
hemodynamic parameters evolution
48 hours
Study Arms (2)
Mild therapeutic hypothermia
EXPERIMENTALSepsis treatment according to standard guidelines plus mild therapeutic hypothermia
Control
NO INTERVENTIONSepsis treatment according to standard guidelines
Interventions
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).
Eligibility Criteria
You may qualify if:
- age \> 18-yrs,
- sedation and mechanical ventilation for at least 48-hrs,
- the diagnosis of septic shock according to standard guidelines.
You may not qualify if:
- bradycardia \< 50 bpm, or any severe ventricular rhythm disturbances,
- pregnancy,
- decision to withdraw or withhold life support,
- predictable death within six hours.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Réanimation Médicale, CHU de la Cavale Blanche
Brest, 29609, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 13, 2010
First Posted
February 17, 2010
Study Start
January 1, 2002
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
February 17, 2010
Record last verified: 2010-02