Mild Therapeutic Hypothermia During Severe Sepsis

Not Applicable

Completed

• Conditions: Sepsis

• 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

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Status Verified: 2010-02
• Study First Submitted: 2010-02-13
• Study First Submitted QC: 2010-02-16
• Last Update Submitted: 2010-02-16
• Study First Posted: 2010-02-17
• Last Update Posted: 2010-02-17

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

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