Prevention of Post-Operative Cardiac Arrhythmias (POCA)

March 12, 2022 updated by: Jeffrey Moak

Multicenter Study for the Prevention of Post-Operative Cardiac Arrhythmias

Aim 1: Primary Prevention of Post-operative Cardiac Arrhythmias

  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. To evaluate medication safety based on the frequency of Serious Adverse Events (SAEs) and Adverse Events (AEs)

Aim 2: Secondary treatment of those Patients that develop a clinically significant arrhythmia despite having received either Dexmedetomidine alone or Magnesium Sulfate with Dexmedetomidine at the time of cardiac surgery

  1. 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.
  2. To evaluate antiarrhythmic medication safety based on the frequency of SAEs and AEs

Study Overview

Detailed Description

Objective: Postoperative cardiac arrhythmias (POCA) are common in children undergoing congenital heart surgery using the heart-lung machine (cardiopulmonary bypass) and have been reported in 5-38% of patients. The occurrence of arrhythmias frequently delays the patient's postoperative recovery, prolongs Cardiac Intensive Care Unit (CICU) and hospital stay, increases costs for hospital care and increases postoperative morbidity and mortality.

Magnesium Sulfate has been one agent used to reduce the occurrence of postoperative arrhythmias. The investigators recently published a propensity-score matched study of the intra-operative administration of Magnesium Sulfate revealing that as many as one-third of pediatric patients at Children's National Hospital undergoing open-heart surgery using cardiopulmonary bypass have postoperative arrhythmias. The use of intraoperative Magnesium Sulfate was associated with a reduction in the occurrence of postoperative arrhythmias. However, despite the intraoperative use of Magnesium Sulfate there continued to be a fairly high residual occurrence rate of post-operative arrhythmias (total arrhythmia frequency -18%).

Dexmedetomidine has also been showed to reduce the occurrence of POCA and has become the preferred agent used for post-operative sedation and pain control. In several studies reported in the medical literature, dexmedetomidine has been found to decrease the occurrence of POCA, like Magnesium Sulfate.

In this IRB study, the investigator is proposing a clinical study to test if the investigator can further decrease the occurrence of postoperative arrhythmias. The investigator will be studying if Magnesium Sulfate administrated in conjunction with an intravenous anesthetic medication, known as dexmedetomidine, can further decrease the primary occurrence of post-operative arrhythmias. The investigator hypothesizes that the effect achieved with the simultaneous administration of Magnesium Sulfate and dexmedetomidine will be much greater than either medication used alone.

For those patients who fail preventative medical strategies and develop clinical significant post-operative arrhythmias in need of treatment, rescue arrhythmia treatment options include the use of potent anti-arrhythmic medications that can have very dramatic effects on the patient's heart rate and blood pressure (amiodarone or procainamide). Scant published data exists providing us with guidance on the comparative efficacy and safety of these agents in the postoperative cardiac surgical patient. The investigator will compare the efficacy and adverse effects of the two agents in treating clinically significant arrhythmias that occur despite trying to prevent their onset.

Study Type

Interventional

Enrollment (Anticipated)

870

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1) 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.
  • 2) No age, gender or ethnic group restrictions.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stage 1, Group 1 - Dexmedetomidine
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
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
Other Names:
  • Precedex
Active Comparator: Stage 1, Group 2- Magnesium
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.
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
Active Comparator: Stage 2, AMIODARONE
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
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
Active Comparator: Stage 2, PROCAINAMIDE
PROCAINAMIDE IV Procainamide 10-15 mg/kg administered over 45 minutes Continuous Intravenous Infusion 20-50 mcg/kg/min
IV Procainamide 10-15 mg/kg administered over 45 minutes Continuous Intravenous Infusion 20-50 mcg/kg/min
Other Names:
  • Pronestyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Post-Operative Cardiac Arrhythmias
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Treatment Success Following IV Amiodarone or Procainamide Administration for Post-Operative Cardiac Arrhythmias.
Time Frame: 3 years
The investigator will determine treatment success (as measured by the composite of complete or partial arrhythmia control) following the administration of either IV amiodarone or procainamide administration. Percent of treatment success will be determined by the composite success group divided by all given administered each anti-arrhythmic agent. Statistical analysis will be performed to determine whether a statistical difference is detected between the two study groups. Arrhythmia control will be determined from continuous cardiac telemetry.
3 years
Incidence of Adverse Effects following IV Amiodarone or Procainamide Administration
Time Frame: 3 years
The investigator will determine the incidence of adverse effects (hypotension, bradycardia, or low cardiac output) following the administration of either IV amiodarone or procainamide. Statistical analysis will be performed to determine whether a statistical difference is detected between the two study groups.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jeffrey Moak, Children's National Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

December 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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