MedTrace Logo

Prevention of Post-Operative Cardiac Arrhythmias

NCT04234906 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 870

Last updated 2022-03-15

No results posted yet for this study

Summary

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

Conditions

  • Cardiac; Dysrhythmia, Postoperative
  • Congenital Heart Surgery

Interventions

DRUG

Dexmedetomidine

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

DRUG

Magnesium Sulfate

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

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

Procainamide

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

Sponsors & Collaborators

  • Jeffrey Moak

    lead OTHER

Principal Investigators

  • Jeffrey Moak · Children's National Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-04-30
Completion
2023-08-31
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04234906 on ClinicalTrials.gov