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Clinical Trials/NCT01069146
NCT01069146CompletedNot Applicable

Mild Therapeutic Hypothermia During Severe Sepsis

University Hospital, Brest2 sites in 1 country20 target enrollmentStarted: January 2002Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
feasibility of hypothermia induction during sepsis
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

feasibility of hypothermia induction during sepsis

Time Frame: 48 hours

Secondary Outcomes

  • hemodynamic parameters evolution(48 hours)

Investigators

Sponsor Class
Other

Study Sites (2)

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