Mild Therapeutic Hypothermia During Severe Sepsis

Sepsis Clinical Trial

Official title:

Mild Therapeutic Hypothermia During Severe Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069146
• Other study ID #: Hymosh
• Status: Completed
• Phase: N/A
• First received: February 13, 2010
• Last updated: February 16, 2010
• Start date: January 2002
• Est. completion date: January 2005

Study information

• Verified date: February 2010
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia
• Sepsis
• Toxemia

Intervention

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).

Locations

Country	Name	City	State
France	Réanimation Médicale, CHU de la Cavale Blanche	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of hypothermia induction during sepsis		48 hours	No
Secondary	hemodynamic parameters evolution		48 hours	No