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Mild Therapeutic Hypothermia During Severe Sepsis

Primary Purpose

Sepsis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mild therapeutic hypothermia induction
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sepsis,, septic shock,, therapeutic hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Réanimation Médicale, CHU de la Cavale Blanche

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mild therapeutic hypothermia

Control

Arm Description

Sepsis treatment according to standard guidelines plus mild therapeutic hypothermia

Sepsis treatment according to standard guidelines

Outcomes

Primary Outcome Measures

feasibility of hypothermia induction during sepsis

Secondary Outcome Measures

hemodynamic parameters evolution

Full Information

First Posted
February 13, 2010
Last Updated
February 16, 2010
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT01069146
Brief Title
Mild Therapeutic Hypothermia During Severe Sepsis
Official Title
Mild Therapeutic Hypothermia During Severe Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
sepsis,, septic shock,, therapeutic hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild therapeutic hypothermia
Arm Type
Experimental
Arm Description
Sepsis treatment according to standard guidelines plus mild therapeutic hypothermia
Arm Title
Control
Arm Type
No Intervention
Arm Description
Sepsis treatment according to standard guidelines
Intervention Type
Procedure
Intervention Name(s)
Mild therapeutic hypothermia induction
Intervention Description
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).
Primary Outcome Measure Information:
Title
feasibility of hypothermia induction during sepsis
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
hemodynamic parameters evolution
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Réanimation Médicale, CHU de la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France

12. IPD Sharing Statement

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