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Cardiac ArrestPhase 2NMB_in_CANCT02260258

Neuromuscular Blockade for Post-Cardiac Arrest Care

A Phase 2 study testing Rocuronium and Normal Saline in people with Cardiac Arrest, run by Beth Israel Deaconess Medical Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to evaluate if neuromuscular blockade improves lactate clearance (and preliminary secondary clinical outcome measures) as compared to usual care in post-cardiac arrest patients undergoing targeted temperature management. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrest
What is being tested?
Rocuronium and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
5 sitesUnited States
Study dates
Oct 2014to 29 May 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adult (≥ 18 years)
  • Cardiac arrest with sustained return of spontaneous circulation (ROSC)
  • Comatose (i.e., not following commands) following ROSC
  • Undergoing targeted temperature management (TTM)
  • Time of enrollment ≤ 6 hours from initiation of targeted temperature management
  • Serum Lactate ≥2

Who cannot join

  • Pre-existing dementia, severe brain injury, or dependence on others for activities of daily living (i.e. a modified Rankin scale (mRS) score of 4 or higher)
  • Traumatic etiology of the cardiac arrest
  • Protected population (pregnant, prisoner)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Michael Kurz

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Robert Swor

    Royal Oak, Michigan, 48073

Other trials in United States

About this study

The main purpose of this study is to evaluate if neuromuscular blockade improves lactate clearance (and preliminary secondary clinical outcome measures) as compared to usual care in post-cardiac arrest patients undergoing targeted temperature management.

Read the detailed description

Out-of-hospital cardiac arrest (OHCA) occurs in more than 300,000 patients in the United States each year with an estimated mortality of greater than 90%. Unfortunately, we currently have little to offer in terms of treatment other than supportive care for the post-cardiac arrest patient. Neuromuscular blockade (NMB) is sometimes utilized in post-arrest patients particularly for the prevention of shivering. However, usage of NMB remains controversial and current American Heart Association (AHA) recommendations are to minimize utilization. Recent prospective randomized trials in patients with acute respiratory distress syndrome suggest a mortality benefit from NMB and an excellent safety profile. Furthermore, observational trials in both sepsis and post-cardiac arrest show that the use of NMB is associated with improved survival. Given this, we hypothesize that continuous NMB will be beneficial in post-arrest patients. In order to test this hypothesis, we propose a multi-center, randomized, open-label, phase II trial in post-CA patients comparing sustained NMB administration for 24 hours to standard of care after return of spontaenous circulation (ROSC). We will enroll adult, comatose OHCA patients with ROSC and will utilize an already existing clinical trials network for the completion of the study. Patients will be randomized to receive either rocuronium for 24 hours or to receive placebo with usual care. Previous data from our group has suggested that lactate levels in the post-arrest patient are a good surrogate marker for mortality. We have therefore chosen to utilize lactate levels at 24 hours as the primary endpoint for the current trial. Secondarily we will evaluate clinical endpoints including length of stay (LOS), in-hospital mortality, and good neurological outcome. We will perform a sub-study of inflammatory markers and oxygen consumption.

Conditions
Cardiac Arrest
Being tested
Rocuronium, Normal Saline
Keywords
Cardiac Arrest, NMB, Neuromuscular Blockade, Rocuronium
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RocuroniumDrug

    Neuromuscular Blockade

  • Normal SalineDrug

    Normal Saline

Study groups in NCT02260258
Study groupRoleWhat they receive
RocuroniumExperimentalPatients will receive a bolus dose of 1 mg/kg, then a continuous intravenous (IV) infusion as per standard intensive care unit practice. Of note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).
Receives: Drug: Rocuronium
Usual CarePlacebo comparatorPatients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.
Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Lactate Over 24 Hours

    Change in median serum lactate level between enrollment and 24-hours after the receipt of study drug. A negative number indicates that the lactate levels were lower at 24 hours compared to their level at receipt of study drug.

    Measured: 24 hours

  2. Change in Lactate Over 24 Hours: Effect Estimate

    Interaction between allocated treatment and time: ratio of geometric mean differences over 24 hours in log lactate values between the two groups.

    Measured: 24 hours

Secondary outcomes (6)

  1. Time ROSC to Target Temperature

    Time from return of spontaneous circulation to target temperature

    Measured: Duration of hospitalization, limit 180 days

  2. Length of Intensive Care Unit (ICU) Stay

    Length of stay in ICU

    Measured: Length of Stay Truncated at 28 Days

  3. Mechanical Ventilation Duration

    Mechanical Ventilation Duration in Hours

    Measured: Duration of hospitalization, limit 180 days

  4. Survival

    In-hospital survival

    Measured: Duration of hospitalization, limit 180 days

  5. Number of Participants With Rankin Score ≤3

    Modified Rankin scale to assess neurological outcome at discharge. The scale ranges from 0 to 6, and is used for measuring the performance of daily activities. The score is as follows:

    • 0: No symptoms
    • 1: No significant disability (able to carry out all usual activities, despite some symptoms)
    • 2: Slight disability (able to look after own affairs without assistance, but unable to carry out all previous activities)
    • 3: Moderate disability (requires some help, but able to walk unassisted)
    • 4: Moderately severe disability (unable to attend to own bodily needs without assistance, and unable to walk unassisted)
    • 5: Severe disability (requires constant nursing care and attention, bedridden, incontinent)
    • 6: Dead.

    Higher cores represent worse outcomes. Good and bad neurological outcome will be defined as a score of 0-3 and 4-6 respectively. This outcome reports the number of patients with a good neurological outcome( modified Rankin score ≤ 3)

    Measured: Duration of hospitalization, limit 180 days

  6. Muscle Weakness Score

    Medical Research Council Scale : Measured for 6 muscle groups (3 in the upper limbs and 3 in the lower limbs). Maximum score is 30 (grade 5 for each group) and minimum is 0 (grade 0 for each group). If muscle group strength was not symmetric bilaterally, higher measurement used. Higher scores indicate better outcomes.

    Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.

    Grade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed.

    Grade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane.

    Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.

    Grade 0: No movement is observed

    Measured: Duration of hospitalization, limit 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion29 May 2019
  4. Study completion29 May 2019

Resources

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02260258
Sponsor's protocol ID
2014P000204
Other IDs
14GRNT20010002
Acronym
NMB_in_CA
Status last verified
Jan 2021
First submitted
24 Sep 2014
Last updated
29 Jan 2021
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Moskowitz A, Andersen LW, Rittenberger JC, Swor R, Seethala RR, Kurz MC, Berg KM, Chase M, Cocchi MN, Grossestreuer AV, Liu X, Holmberg MJ, Callaway CW, Donnino MW. Continuous Neuromuscular Blockade Following Successful Resuscitation From Cardiac Arrest: A Randomized Trial. J Am Heart Assoc. 2020 Sep;9(17):e017171. doi: 10.1161/JAHA.120.017171. Epub 2020 Aug 27.

    PubMed 32851921

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rocuronium and Normal Saline in people with Cardiac Arrest, run by Beth Israel Deaconess Medical Center at 5 sites in United States.

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 6 inclusion and 3 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Lactate Over 24 Hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02260258, 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 29 Jan 2021.

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