Mild Therapeutic Hypothermia During Severe Sepsis
Not Applicable
Completed
- Conditions
- Sepsis
- Interventions
- Procedure: Mild therapeutic hypothermia induction
- Registration Number
- NCT01069146
- Lead Sponsor
- University Hospital, Brest
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mild therapeutic hypothermia Mild therapeutic hypothermia induction Sepsis treatment according to standard guidelines plus mild therapeutic hypothermia
- Primary Outcome Measures
Name Time Method feasibility of hypothermia induction during sepsis 48 hours
- Secondary Outcome Measures
Name Time Method hemodynamic parameters evolution 48 hours
Trial Locations
- Locations (1)
Réanimation Médicale, CHU de la Cavale Blanche
🇫🇷Brest, France