Mild Therapeutic Hypothermia During Severe Sepsis

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT01069146

First received: February 13, 2010

Last updated: February 16, 2010

Last verified: February 2010

History of Changes

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Mild Therapeutic Hypothermia During Severe Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia Sepsis Shock

U.S. FDA Resources

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:

feasibility of hypothermia induction during sepsis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

hemodynamic parameters evolution [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069146

Locations

France
Réanimation Médicale, CHU de la Cavale Blanche
Brest, France, 29609

Sponsors and Collaborators

University Hospital, Brest

More Information

No publications provided

Responsible Party:	Pr Erwan L'HER, MD, PhD, CHU Brest
ClinicalTrials.gov Identifier:	NCT01069146 History of Changes
Other Study ID Numbers:	Hymosh
Study First Received:	February 13, 2010
Last Updated:	February 16, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:

sepsis,
septic shock,
therapeutic hypothermia

Additional relevant MeSH terms:

Hypothermia
Sepsis
Toxemia
Body Temperature Changes
Signs and Symptoms

Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013

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