Prevention of Post-Operative Cardiac Arrhythmias

NCT04234906 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: Pro00013067
• Study Type: interventional
• Target: 870
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim 1: Primary Prevention of Post-operative Cardiac Arrhythmias

1. 1.To evaluate the efficacy of dexmedetomidine vs. the combination of Magnesium Sulfate and dexmedetomidine for the prevention of post-operative cardiac arrhythmias in children and young adults undergoing open heart surgical repair for congenital or acquired heart disease using cardiopulmonary bypass. Dexmedetomidine is currently being administered to almost all patients after coming off cardiopulmonary bypass and in the CICU. For this aim, the investigator will be comparing dexmedetomidine administered alone or in combination with Magnesium Sulfate.
2. 2.To evaluate medication safety based on the frequency of Serious Adverse Events (SAEs) and Adverse Events (AEs)
3. 3.To evaluate the efficacy of intravenous (IV) Amiodarone vs. IV Procainamide for the control of postoperative cardiac arrhythmias developing after the failure of Stage 1, Preventative Trial. IV amiodarone and IV procainamide are standardly used treatment agents for the treatment of postoperative cardiac arrhythmias in this setting. The investigator will be assessing the comparative effectiveness of these agents in controlling post-operative cardiac arrhythmias.
4. 4.To evaluate antiarrhythmic medication safety based on the frequency of SAEs and AEs

Conditions

Cardiac; Dysrhythmia, Postoperative; Congenital Heart Surgery

Keywords

Magnesium Sulfate; Dexedetomidine; anti-arrhythmic medications

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-Operative Cardiac Arrhythmias

  The investigator will determine the incidence of cardiac arrhythmia in the two study groups (dexmedetomidine and magnesium sulfate). Statistical analysis will be performed to determine whether a statistical difference is detected between the two study groups. The occurrence of cardiac arrhythmias will be determined from continuous cardiac telemetry.

  3 years

Secondary Outcomes (2)

• Percent of Treatment Success Following IV Amiodarone or Procainamide Administration for Post-Operative Cardiac Arrhythmias.

  3 years

• Incidence of Adverse Effects following IV Amiodarone or Procainamide Administration

  3 years

Study Arms (4)

Stage 1, Group 1 - Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine: 1 mcg/kg administered at end of cardiopulmonary bypass, followed by a 0.5 mcg/kg/h infusion for 72 h postoperatively or ready for extubation prior to 72 hour time period

Drug: Dexmedetomidine

Stage 1, Group 2- Magnesium

ACTIVE COMPARATOR

Magnesium Sulfate (50 mg/kg) bolus administered at the time of Aortic Cross Clamp Release, with continued administration for 72 hours postoperatively at a dose of 30 mg/kg/day.

Drug: Magnesium Sulfate

Stage 2, AMIODARONE

ACTIVE COMPARATOR

AMIODARONE I V Amiodarone 2.5 mg/kg administered over 30 minutes Second 2.5 mg/kg dose if needed over 30 minutes Continuous Intravenous Infusion 10-15 mg/kg/24 hours

Drug: Amiodarone

Stage 2, PROCAINAMIDE

ACTIVE COMPARATOR

PROCAINAMIDE IV Procainamide 10-15 mg/kg administered over 45 minutes Continuous Intravenous Infusion 20-50 mcg/kg/min

Drug: Procainamide

Interventions

Dexmedetomidine DRUG

Dexmedetomidine: 1 mcg/kg administered over 20 min peri-intubation period, followed by a 0.5 mcg/kg/h infusion for 72 h postoperatively or ready for extubation prior to 72 hour time period

Also known as: Precedex

Stage 1, Group 1 - Dexmedetomidine

Magnesium Sulfate DRUG

Magnesium Sulfate (50 mg/kg) bolus administered at the time of Aortic Cross Clamp Release, with continued administration for 72 hours postoperatively at a dose of 30 mg/kg/day

Stage 1, Group 2- Magnesium

Amiodarone DRUG

I V Amiodarone 2.5 mg/kg administered over 30 minutes Second 2.5 mg/kg dose if needed over 30 minutes Continuous Intravenous Infusion 10-15 mg/kg/24 hours

Stage 2, AMIODARONE

Procainamide DRUG

IV Procainamide 10-15 mg/kg administered over 45 minutes Continuous Intravenous Infusion 20-50 mcg/kg/min

Also known as: Pronestyl

Stage 2, PROCAINAMIDE

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) Any infant, child, adolescent, or young adult with congenital or acquired heart disease undergoing open heart surgical repair using cardiopulmonary bypass is eligible to be enrolled in this trial.
• \) No age, gender or ethnic group restrictions.

You may not qualify if:

• \) Non-cardiopulmonary bypass repair of a congenital or acquired cardiac defect.
• \) Significant pre-operative arrhythmia history
• \) Past history of adverse effect to any of the study medication agents

Sponsors & Collaborators

• Jeffrey Moak: lead

Related Publications (26)

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• He D, Aggarwal N, Zurakowski D, Jonas RA, Berul CI, Hanumanthaiah S, Moak JP. Lower risk of postoperative arrhythmias in congenital heart surgery following intraoperative administration of magnesium. J Thorac Cardiovasc Surg. 2018 Aug;156(2):763-770.e1. doi: 10.1016/j.jtcvs.2018.04.044. Epub 2018 Apr 18.

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• He D, Sznycer-Taub N, Cheng Y, McCarter R, Jonas RA, Hanumanthaiah S, Moak JP. Magnesium Lowers the Incidence of Postoperative Junctional Ectopic Tachycardia in Congenital Heart Surgical Patients: Is There a Relationship to Surgical Procedure Complexity? Pediatr Cardiol. 2015 Aug;36(6):1179-85. doi: 10.1007/s00246-015-1141-5. Epub 2015 Mar 12.

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• Lapsa J, Clark B, Chen YI, Moak JP. Incidence and risk factors for development of post-operative bradyarrhythmias following congenital and acquired cardiac disease repair in pediatric patients. Poster at APS, Baltimore, MD, 2019.

  BACKGROUND

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MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Dexmedetomidine; Magnesium Sulfate; Amiodarone; Procainamide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jeffrey Moak

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Moak

CONTACT

2024765707; JMOAK@childrensnational.org

Robert Lowndes

CONTACT

202-476-4970; rlowndes@childrensnational.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be randomized within each participating center, not by center, into study groups: Stage 1: Group 1 - Dexmedetomidine vs. Group 2- Magnesium Sulfate + Dexmedetomidine Stage 2: If clinically significant arrhythmias in need of treatment develop, patients will be randomized to Group 1 - amiodarone vs. procainamide. Randomization will occur through a module in Redcap.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Electrophysiology and Pacing, Principle Investigator, Clinical Professor

Model Details: Two staged, prospective randomized clinical trial: Stage 1 targets prevention of post-operative arrhythmias. Stage 2 allows for re-randomization to secondary treatment for those subjects failing Stage 1, i.e. those patients that develop and require treatment of clinically significant post-operative cardiac arrhythmias with antiarrhythmic medication.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 21, 2020
• Study Start: January 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 15, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share