Influence of Therapeutic Hypothermia on Resting Energy Ex... | NCT00500825

Studies
Influence of Therapeutic Hypothermia on Resting Energy Expenditure

NCT00500825

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

May 16, 2008Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Cardiopulmonary Resuscitation

Interventions

Measurement of Resting Energy Expenditure

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Mar 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jul 11, 2007

First Submission Date that Met QC Criteria

Jul 11, 2007

First Posted Date

Jul 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2008

Last Update Posted Date

May 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is the evaluation of the influence of therapeutic hypothermia on resting energy expenditure (REE) in patients after cardiopulmonary resuscitation (CPR). We hypothesized that hypothermia would reduce resting energy expenditure in these patients.

Detailed Description

Therapeutic hypothermia improves neurologic outcome in patients after cardiopulmonary resuscitation (CPR) because of cardiac arrest. In the present study patients will be cooled to 33 degree Celsius after CPR for 24h. To avoid shivering patients will be analgosedated and medically paralysed. Analgosedation and relaxation have already shown to reduce oxygen consumption up to 20 % in critically ill patients.

In patients with brain injury, who were cooled to 33 degree Celsius using a cooling meadow REE could be significantly reduced. In critically ill patients with pyrexia cooling using a cooling meadow REE could be reduced. Oxygen consumption was reduced about 14,7% per degree Celsius.

So far no studies evaluating influence of therapeutic hypothermia on REE in patients after CPR have been published. Therefore we plan to measure REE in 25 cooled patients after CPR using indirect Calorimetry (Deltatrac II Metabolic Monitor, Datex Instrumentarium, Helsinki, Finland).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients successfully resuscitated after cardiac arrest undergoing therapeutic hypothermia	Procedure: Measurement of Resting Energy Expenditure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of Resting Energy Expenditure	Procedure	Non-invasive measurement of Resting Energy Expenditure	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

St.p. CPR
Indication for therapeutic hypothermia for 24h (33 degrees Celsius)

Exclusion Criteria:

Contraindication for therapeutic hypothermia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Residents of Vienna

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrike Holzinger, MD	Medical University Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Vienna		Vienna	State of Vienna	1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25888299	Derived	Holzinger U, Brunner R, Losert H, Fuhrmann V, Herkner H, Madl C, Sterz F, Schneeweiss B. Resting energy expenditure and substrate oxidation rates correlate to temperature and outcome after cardiac arrest - a prospective observational cohort study. Crit Care. 2015 Mar 29;19(1):128. doi: 10.1186/s13054-015-0856-2.