Cardiac Arrest With Successful ResuscitationPhase 3RELAXNCT01719770
Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest
A Phase 3 study testing rocuronium in people with Cardiac Arrest With Successful Resuscitation and Hypothermia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest With Successful Resuscitation, Hypothermia, Skeletal Muscle Relaxant Overdose
- What is being tested?
- rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2010to Apr 2015
- Phase
- Phase 3
- 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
- cardiac arrest due to cardiopulmonary origin
Who cannot join
- patients younger than 18 years
- traumatic cardiac arrest
- cardiac arrest due to exsanguination, strangulation, smoke inhalation, drug overdose, electrocution, hanging or drowning
- known or clinically apparent pregnancy
- no treatment with mild therapeutic hypothermia because of an AND order
- terminal illness
Show all 13Show fewer
- a body core temperature below 35°C at hospital admission
- known allergic reaction against rocuronium
- history of myasthenia gravis
- obvious intoxication
- ward of the state or prisoner
- known epileptic disease
- cardiac arrest >6 hours prior to hospital admission
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Emergency Medicine
Vienna, State of Vienna, 1190
About this study
Official title: Requirement of Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest - a Pilot Study
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. Since neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolong ICU stay. So economical use seems to be reasonable. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, post hypoxic seizures might remain undetected.
Aim of this study is to investigate if a continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoid the counter regulation to achieve the target temperature as soon as possible in mild hypothermic therapy after cardiac arrest.
Read more
A single center (university hospital) study. Randomized, double blinded, double dummy study design. Eligible are all adult patients after successful resuscitation due to cardiac arrest of presumed cardiac origin.
All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin will be included.
Patients <18 years, 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, patients with obvious intoxication, wards of the state/prisoners and patients with known epileptic disease will be excluded.
Primary outcome:
Shivering episodes will be scored with the Shivering Assessment Scale.
Secondary outcome:
Total doses of rocuronium, time to target core temperature of 33°C, dissipated energy and total energy needed during the cooling period will be compared between the two groups.
Changes in basal metabolism and depth of relaxation will be ascertained. Furthermore, serum levels of midazolam, fentanyl, rocuronium and stress hormones will be measured.
Train-of-four will be performed to assess the depth of relaxation. Sedation will be monitored via bispectral index; measurement of metabolic activity will be evaluated using indirect calorimetry. Additionally, EEG will be performed to detect epileptiform activities. Blood will be drawn to measure levels of midazolam, fentanyl and rocuronium.
- Conditions
- Cardiac Arrest With Successful Resuscitation, Hypothermia, Skeletal Muscle Relaxant Overdose
- Being tested
- rocuronium, placebo
- Keywords
- cardiac arrest, therapeutic hypothermia, skeletal muscle paralysis, shivering, serum drug levels, basal metabolism
- Medical subject headings
- Hypothermia, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rocuroniumDrug
Also called Esmeron
continuous application of rocuronium 0,25mg/kg/h (blinded), in case of shivering episode bolus sodium-chloride (blinded)
placeboOther
Also called sodium-chloride
continuous infusion of sodium-chloride (blinded), in case of shivering episode application of rocuronium 0,25mg/kg (blinded)
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium | Active comparator | Continuous infusion of rocuronium with 0,25mg/kg (blinded) for 29 hours after initiation of mild therapeutic hypothermia Receives: Drug: rocuronium |
| Placebo | Placebo comparator | Continuous infusion of sodium-chloride (placebo) and rocuronium bolus (0,25mg/kg)in case of shivering episode (blinded) Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of shivering episodes
Shivering episodes will be detected according to the Shivering Assessment Scale
Measured: during cooling period (mild therapeutic hypothermia will be performed for 24 hours after cooling initiation, rewarming with 0,4°C per hour until a body core temperature of 36°C is reached); total time of approximately 31 hours
Secondary outcomes (6)
Elapsed time to target temperature
Measured: Time from starting the cooling procedure until target temperature is reached - approximately 4 hours after cooling initiation
Dissipated energy to reach the target temperature
Measured: Time from starting the cooling procedure until target temperature is reached - approximately 4 hours after cooling initiation
Changes in basal metabolism due to shivering or elevated stress levels
Measured: during the first 72 hours after cardiac arrest
Depth of relaxation
via train of four measurement
Measured: during cooling and rewarming period, which will be approximately 30 hours up to 48 hours after initiation of cooling
Changes in serum levels of midazolam, fentanyl and rocuronium
Measured: within the first 48 hours of treatment
Number of necessary boli of rocuronium
In case of a shivering episode, a bolus of rocuronium will be administered (0,25mg/kg)
Measured: during colling period (mild therapeutic hypothermia will be performed for 24 hours after cooling initiation, rewarming with 0,4°C per hour until a body core temperature of 36°C is reached); total time of approximately 31 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startNov 2010
- Primary completionOct 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest With Successful 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidrun Losert, Medical University of Vienna
- Investigators
- Heidrun Losert, MD, Principal investigator, Medical University Vienna, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719770
- Sponsor's protocol ID
- RELAX1
- Acronym
- RELAX
- Status last verified
- Apr 2015
- First submitted
- 6 Jul 2011
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Requirement of Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest - a Pilot Study
- ClinicalTrials.gov ID
- NCT01719770
- Acronym / sponsor ID
- RELAX / RELAX1
- Conditions
- Cardiac Arrest With Successful Resuscitation, Hypothermia, Skeletal Muscle Relaxant Overdose
- Keywords
- cardiac arrest, therapeutic hypothermia, skeletal muscle paralysis, shivering, serum drug levels, basal metabolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Nov 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.
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. Since neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolong ICU stay. So economical use seems to be reasonable. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, post hypoxic seizures might remain undetected.
Aim of this study is to investigate if a continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoid the counter regulation to achieve the target temperature as soon as possible in mild hypothermic therapy after cardiac arrest.
A single center (university hospital) study. Randomized, double blinded, double dummy study design. Eligible are all adult patients after successful resuscitation due to cardiac arrest of presumed cardiac origin.
All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin will be included.
Patients <18 years, 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, patients with obvious intoxication, wards of the state/prisoners and patients with known epileptic disease will be excluded.
Primary outcome:
Shivering episodes will be scored with the Shivering Assessment Scale.
Secondary outcome:
Total doses of rocuronium, time to target core temperature of 33°C, dissipated energy and total energy needed during the cooling period will be compared between the two groups.
Changes in basal metabolism and depth of relaxation will be ascertained. Furthermore, serum levels of midazolam, fentanyl, rocuronium and stress hormones will be measured.
Train-of-four will be performed to assess the depth of relaxation. Sedation will be monitored via bispectral index; measurement of metabolic activity will be evaluated using indirect calorimetry. Additionally, EEG will be performed to detect epileptiform activities. Blood will be drawn to measure levels of midazolam, fentanyl and rocuronium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium | Active comparator | Drug: rocuroniumContinuous infusion of rocuronium with 0,25mg/kg (blinded) for 29 hours after initiation of mild therapeutic hypothermia |
| Placebo | Placebo comparator | Other: placeboContinuous infusion of sodium-chloride (placebo) and rocuronium bolus (0,25mg/kg)in case of shivering episode (blinded) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients receiving mild therapeutic hypothermia after cardiac arrest
- cardiac arrest due to cardiopulmonary origin
Key exclusion criteria (13 listed)
- patients younger than 18 years
- traumatic cardiac arrest
- cardiac arrest due to exsanguination, strangulation, smoke inhalation, drug overdose, electrocution, hanging or drowning
- known or clinically apparent pregnancy
- no treatment with mild therapeutic hypothermia because of an AND order
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 |
|---|---|---|
| rocuroniumAlso: Esmeroncontinuous application of rocuronium 0,25mg/kg/h (blinded), in case of shivering episode bolus sodium-chloride (blinded) | Drug | Rocuronium |
| placeboAlso: sodium-chloridecontinuous infusion of sodium-chloride (blinded), in case of shivering episode application of rocuronium 0,25mg/kg (blinded) | Other | Placebo |
Primary outcome
Number of shivering episodes
Time frame: during cooling period (mild therapeutic hypothermia will be performed for 24 hours after cooling initiation, rewarming with 0,4°C per hour until a body core temperature of 36°C is reached); total time of approximately 31 hours
Shivering episodes will be detected according to the Shivering Assessment Scale
6 secondary outcomes
Elapsed time to target temperature
Time frame: Time from starting the cooling procedure until target temperature is reached - approximately 4 hours after cooling initiation
Dissipated energy to reach the target temperature
Time frame: Time from starting the cooling procedure until target temperature is reached - approximately 4 hours after cooling initiation
Changes in basal metabolism due to shivering or elevated stress levels
Time frame: during the first 72 hours after cardiac arrest
Depth of relaxation
Time frame: during cooling and rewarming period, which will be approximately 30 hours up to 48 hours after initiation of cooling
Changes in serum levels of midazolam, fentanyl and rocuronium
Time frame: within the first 48 hours of treatment
Number of necessary boli of rocuronium
Time frame: during colling period (mild therapeutic hypothermia will be performed for 24 hours after cooling initiation, rewarming with 0,4°C per hour until a body core temperature of 36°C is reached); total time of approximately 31 hours
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 1 May 2015.
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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.
Heidrun Losert, MD principal investigator
Medical University Vienna, Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rocuronium in people with Cardiac Arrest With Successful Resuscitation and Hypothermia, 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 13 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 1 May 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of shivering episodes (time frame: during cooling period (mild therapeutic hypothermia will be performed for 24 hours after cooling initiation, rewarming with 0,4°C per hour until a body core temperature of 36°C is reached); total time of approximately 31 hours). 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 1 May 2015.