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Mild Therapeutic Hypothermia During Severe Sepsis

This study has been completed.
Information provided by:
University Hospital, Brest Identifier:
First received: February 13, 2010
Last updated: February 16, 2010
Last verified: February 2010

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.

Condition Intervention
Sepsis Procedure: Mild therapeutic hypothermia induction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mild Therapeutic Hypothermia During Severe Sepsis

Resource links provided by NLM:

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • feasibility of hypothermia induction during sepsis [ Time Frame: 48 hours ]

Secondary Outcome Measures:
  • hemodynamic parameters evolution [ Time Frame: 48 hours ]

Enrollment: 20
Study Start Date: January 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mild therapeutic hypothermia
Sepsis treatment according to standard guidelines plus mild therapeutic hypothermia
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).
No Intervention: Control
Sepsis treatment according to standard guidelines


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01069146

Réanimation Médicale, CHU de la Cavale Blanche
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
  More Information

Responsible Party: Pr Erwan L'HER, MD, PhD, CHU Brest Identifier: NCT01069146     History of Changes
Other Study ID Numbers: Hymosh
Study First Received: February 13, 2010
Last Updated: February 16, 2010

Keywords provided by University Hospital, Brest:
septic shock,
therapeutic hypothermia

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Body Temperature Changes
Signs and Symptoms processed this record on June 22, 2017