Critical IllnessNCT01683006
Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
A study testing Rocuronium in people with Critical Illness and Cardiac Arrest, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Cardiac Arrest
- What is being tested?
- Rocuronium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2012to Nov 2014
- Phase
- Interventional
- 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
Who may be able to join
- All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin
Who cannot join
- age < 18
- cardiac arrest >6 hours before admittance at the hospital
- patients with known or clinically apparent pregnancy
- patients who reach our hospital with a body temperature below 35°C
- patients with known allergic reactions against rocuronium
- patients with a history of myasthenia gravis
Show all 9Show fewer
- patients with obvious intoxication
- wards of the state/prisoners
- patients with known epileptic disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.
Read the detailed description
Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers are in use, together with analgesia and sedation, during the cooling process in many centers to prevent shivering. However, neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolonged ICU stay. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, the advantages and disadvantages of neuromuscular blockers during therapeutic hypothermia need to be re-evaluated.
Aim of this study is to investigate if continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoiding an increase in energy expenditure in patients during therapeutic hypothermia and rewarming after cardiac arrest (initial 72h).
- Conditions
- Critical Illness, Cardiac Arrest
- Being tested
- Rocuronium, Placebo
- Medical subject headings
- Critical Illness, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Continuous application of Rocuronium (0.5 mg/kg body weight/hour).
Bolus application of placebo in case of shivering.
PlaceboDrug
Continuous application of placebo during therapeutic hypothermia.
Bolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular blocker group | Active comparator | Continuous application of neuromuscular blockers during therapeutic hypothermia.
Bolus application of placebo in case of shivering. Receives: Drug: Rocuronium |
| Placebo group | Placebo comparator | Continuous application of placebo during therapeutic hypothermia.
Bolus application of neuromuscular blockers in case of shivering. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of resting energy expenditure compared to baseline at 33C°
resting energy expenditure will be assessed with indirect calorimetry at different measurement time points:
- 12-24 h after initiation of mild hypothermia (33C°)
- during warming up (at 34.5°C)
- during warming up (at 36°C)
- during warming up (at 36.5°C - 37.5°C)
- normal Temperature, after 48 - 72 h after initiation of mild hypothermia
Measured: initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h
Secondary outcomes (1)
Change of substrate oxidation rate (protein, fat and glucose) compared to baseline at 33C°
substrate oxidation rates will be assessed with indirect calorimetry at different measurement time points:
- 12-24 h after initiation of mild hypothermia (33C°)
- during warming up (at 34.5°C)
- during warming up (at 36°C)
- during warming up (at 36.5°C - 37.5°C)
- at normal Temperature, after 48 - 72 h after initiation of mild hypothermia
Measured: initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Holzinger, Medical University of Vienna
- Investigators
- Ulrike Holzinger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683006
- Sponsor's protocol ID
- 753/2009UH
- Status last verified
- Aug 2017
- First submitted
- 8 Apr 2012
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01683006
- Acronym / sponsor ID
- 753/2009UH
- Conditions
- Critical Illness, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Sep 2012 (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 to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.
Detailed description
Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers are in use, together with analgesia and sedation, during the cooling process in many centers to prevent shivering. However, neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolonged ICU stay. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, the advantages and disadvantages of neuromuscular blockers during therapeutic hypothermia need to be re-evaluated.
Aim of this study is to investigate if continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoiding an increase in energy expenditure in patients during therapeutic hypothermia and rewarming after cardiac arrest (initial 72h).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular blocker group | Active comparator | Drug: RocuroniumContinuous application of neuromuscular blockers during therapeutic hypothermia. Bolus application of placebo in case of shivering. |
| Placebo group | Placebo comparator | Drug: PlaceboContinuous application of placebo during therapeutic hypothermia. Bolus application of neuromuscular blockers in case of shivering. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin
Key exclusion criteria (9 listed)
- age < 18
- cardiac arrest >6 hours before admittance at the hospital
- patients with known or clinically apparent pregnancy
- patients who reach our hospital with a body temperature below 35°C
- patients with known allergic reactions against rocuronium
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 |
|---|---|---|
| RocuroniumContinuous application of Rocuronium (0.5 mg/kg body weight/hour). Bolus application of placebo in case of shivering. | Drug | Neuromuscular blocker group |
| PlaceboContinuous application of placebo during therapeutic hypothermia. Bolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering. | Drug | Placebo group |
Primary outcome
Change of resting energy expenditure compared to baseline at 33C°
Time frame: initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h
resting energy expenditure will be assessed with indirect calorimetry at different measurement time points: 1. 12-24 h after initiation of mild hypothermia (33C°) 2. during warming up (at 34.5°C) 3. during warming up (at 36°C) 4. during warming up (at 36.5°C - 37.5°C) 5. normal Temperature, after 48 - 72 h after initiation of mild hypothermia
1 secondary outcome
Change of substrate oxidation rate (protein, fat and glucose) compared to baseline at 33C°
Time frame: initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h
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 29 Aug 2017.
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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?
A study testing Rocuronium in people with Critical Illness and Cardiac Arrest, 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 1 inclusion and 9 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 29 Aug 2017. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Change of resting energy expenditure compared to baseline at 33C° (time frame: initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2017.