Cardiopulmonary ResuscitationNCT00500825
Influence of Therapeutic Hypothermia on Resting Energy Expenditure
An observational study of Cardiopulmonary Resuscitation, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- Measurement of Resting Energy Expenditure
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2005to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents of Vienna
Who may be able to join
- St.p. CPR
- Indication for therapeutic hypothermia for 24h (33 degrees Celsius)
Who cannot join
- Contraindication for therapeutic hypothermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Therapeutic Hypothermia on Resting Energy Expenditure in Patients After Cardiopulmonary Resuscitation
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.
Read the 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).
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- Measurement of Resting Energy Expenditure
- Keywords
- Cardiopulmonary resuscitation, Therapeutic hypothermia, resting energy expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Resting Energy ExpenditureProcedure or surgery
Also called Deltatrac (Ohmeda)
Non-invasive measurement of Resting Energy Expenditure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients successfully resuscitated after cardiac arrest undergoing therapeutic hypothermia Receives: Procedure: Measurement of Resting Energy Expenditure |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startJul 2005
- Primary completionMar 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Ulrike Holzinger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500825
- Sponsor's protocol ID
- 486/2003
- Status last verified
- May 2008
- First submitted
- 11 Jul 2007
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25888299
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Therapeutic Hypothermia on Resting Energy Expenditure in Patients After Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT00500825
- Acronym / sponsor ID
- 486/2003
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- Cardiopulmonary resuscitation, Therapeutic hypothermia, resting energy expenditure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Measurement of Resting Energy ExpenditurePatients successfully resuscitated after cardiac arrest undergoing therapeutic hypothermia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Vienna
Key inclusion criteria (2 listed)
- St.p. CPR
- Indication for therapeutic hypothermia for 24h (33 degrees Celsius)
Key exclusion criteria (1 listed)
- Contraindication for therapeutic hypothermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Resting Energy ExpenditureAlso: Deltatrac (Ohmeda)Non-invasive measurement of Resting Energy Expenditure | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2008.
- Derived from this study: PubMed 25888299Holzinger 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.
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The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
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RecruitingObservational study
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Cardiac Arrest, Out-Of-Hospital, Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Holzinger, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Resuscitation, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2008.