Mild Therapeutic Hypothermia During Severe Sepsis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Réanimation Médicale, CHU de la Cavale Blanche

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mild therapeutic hypothermia induction

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).

Primary outcomes

feasibility of hypothermia induction during sepsis

Time frame: 48 hours

Secondary outcomes

hemodynamic parameters evolution

Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2005
First posted: Feb 17, 2010
Registry last updated: Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed