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Mild Therapeutic Hypothermia During Severe Sepsis

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ClinicalTrials.gov Identifier: NCT01069146
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : February 17, 2010
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Sepsis Procedure: Mild therapeutic hypothermia induction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mild Therapeutic Hypothermia During Severe Sepsis
Study Start Date : January 2002
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia Sepsis
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069146


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

Responsible Party: Pr Erwan L'HER, MD, PhD, CHU Brest
ClinicalTrials.gov Identifier: NCT01069146     History of Changes
Other Study ID Numbers: Hymosh
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: February 2010

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

Additional relevant MeSH terms:
Sepsis
Toxemia
Hypothermia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Body Temperature Changes
Signs and Symptoms