Mild Therapeutic Hypothermia During Severe Sepsis

NCT ID: NCT01069146

Last Updated: 2010-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2005-01-31

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild therapeutic hypothermia

Sepsis treatment according to standard guidelines plus mild therapeutic hypothermia

Group Type: EXPERIMENTAL

Mild therapeutic hypothermia induction

Intervention Type: PROCEDURE

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).

Control

Sepsis treatment according to standard guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

CHU Brest

Locations

Réanimation Médicale, CHU de la Cavale Blanche

Brest, , France

Countries

France

Other Identifiers

Hymosh

Identifier Type: -

Identifier Source: org_study_id