Mild Therapeutic Hypothermia During Severe Sepsis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01069146

Enrollment

Registered

2010-02-17

Start date

2002-01-31

Completion date

2005-01-31

Last updated

2010-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis,, septic shock,, therapeutic hypothermia

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.

Interventions

PROCEDUREMild 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
feasibility of hypothermia induction during sepsis	48 hours

Secondary

Measure	Time frame
hemodynamic parameters evolution	48 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026