Mild Therapeutic Hypothermia During Severe Sepsis

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Sepsis

Treatments: Procedure: Mild therapeutic hypothermia induction

Study type: Interventional

Funder types: Other

Identifiers

NCT01069146

Hymosh

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Mild therapeutic hypothermia

Experimental group

Description:

Sepsis treatment according to standard guidelines plus mild therapeutic hypothermia

Treatment:

Procedure: Mild therapeutic hypothermia induction

Control

No Intervention group

Description:

Sepsis treatment according to standard guidelines