Biventricular Pacing in Children After Surgery for Congenital Heart Disease
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|ClinicalTrials.gov Identifier: NCT02806245|
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease (CHD)||Other: Biventricular pacing||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Biventricular Pacing in Children After Surgery for Congenital Heart Disease|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Biventricular pacing
Patients will be randomized pre-operatively to either the pacing group or to the control group. Patients randomized to receive pacing will 1st undergo an acute pacing phase where the order of the pacing mode will be randomized and then will continue to an extended pacing phase of biventricular pacing.
Other: Biventricular pacing
Randomization into one of 3 study arms for acute phase and for extended phase.
Measurement of baseline variables on arrival to CCU. Acute pacing protocol (order of pacing randomized):
Measure hemodynamic variables 30 min after start of pacing. Pacing hiatus for 60 minutes at 24 hours with measurement of hemodynamics without pacing and after reinitiating pacing.
Stop pacing at 72 hours or after extubation, whichever comes first. For those patients who are extubated before 72 hours: measurements will be taken before extubation and one hour after extubation. Pacing will then be stopped.
No Intervention: Control
Controls will receive standard of care treatment consisting of placement of 2 pacing leads (right atrial and right ventricular), monitoring of the study outcomes, monitoring of oxygen consumption and echocardiography, but no pacing.
- Change in mean cardiac index [ Time Frame: Baseline to 72 hours ]1. Change in mean cardiac index (as measured by the Fick method with respiratory mass spectroscopy for VO2) from baseline to 48 postoperative hours after arrival in the CCCU, recorded every 6 hours up to 72 hours and at each time blood gases sampled.
- Composite clinical score [ Time Frame: Baseline to 72 hours ]a.Time until first negative fluid balance b.Time until sternal closure c.Time until first planned extubation d.In-hospital death e.Extracorporeal membrane oxygenation
- Oxygen consumption [ Time Frame: Every hour for 1st 24 hrs and then every 6hours ]2. Oxygen consumption (respiratory mass spectroscopy), measured continuously, recorded every hour for the 1st 24 hours, then every 6 hours and at each blood gas sampling.
- Intracardiac pressures (RA, LA, CVP, PA) [ Time Frame: Every hour for the 1st 24 hours, then every 6 hours until lines removed ]Intracardiac pressures (RA, LA, CVP, PA) measured continuously, recorded every hour for the 1st 24 hours, then every 6 hours until lines removed.
- Mean inotrope score [ Time Frame: every hour for the 1st 24 hours, then every 6 hours ]Mean inotrope score recorded every hour for the 1st 24 hours, then every 6 hours.
- Mean airway pressure [ Time Frame: every hour for the 1st 24 hours, then every 6 hours ]Mean airway pressure recorded every hour for the 1st 24 hours, then every 6 hours (simultaneously with inotrope score)
- Serum Lactate [ Time Frame: Over 72 hours recorded every 6 hours ]Serum lactate over 72 hours, recorded every 6 hours.
- Blood pressure [ Time Frame: over 72 hours, recorded every hour for the 1st 24 hours and then every 6hours ]Blood pressure over 72 hours, recorded every hour for the 1st 24 hours and then every 6 hours
- Length of stay in CCCU [ Time Frame: Over 72 hours ]Length of stay in CCCU (recorded in hours).
- Electrical dyssynchrony [ Time Frame: Baseline and 48 hours ]Electrical dyssynchrony at 48 hours (QRS duration in msec from 6-lead limb ECG).
- Echocardiograms [ Time Frame: Baseline and 48 hours ]Echocardiograms will be done at baseline (after arrival in CCCU, before pacing) and at 48 hours after arrival to the CCCU to assess mechanical dyssynchrony.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806245
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G1X8|
|Principal Investigator:||Mark K Friedberg, MD||The Hospital for Sick Children|