Biventricular Pacing in Children With Congenital Heart Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02644824|
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease (CHD)||Device: Biventricular Pacing (BiVp)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Biventricular Pacing in Children With Wide QRS After Surgery for Congenital Heart Disease|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
Experimental: Biventricular Pacing (BiVp)
Consented infants with wide QRS randomized to receive standard of care and BiVp.
Device: Biventricular Pacing (BiVp)
BiVp shortens QRS duration and synchronizes ventricular contraction; thereby decreasing wall stress and increasing CI and BP. In contrast to inotropes, BiVp does not increase myocardial VO2. Resynchronizing myocardial contraction normalizes glucose metabolism, myocardial perfusion and distribution of proteins essential to myocardial contraction and relaxation such as calcium-handling phospholamban. Overall, BiVp improves pump function, increases CI, improves myocardial perfusion and reduces VO2, improving hemodynamics.
No Intervention: Control (wide QRS)
Consented infants with wide QRS randomized to receive standard of care alone.
No Intervention: Control (narrow QRS)
This is an observation control group. Consented infants with narrow QRS will enter control group 2 without randomization.
- Change in Cardiac Index (CI) [ Time Frame: Pre-operative, baseline, and every 24 hours during care up to 48 hours ]The overall mean change in CI from baseline (average of 1st 2 CI measurements) to study end (average of last 2 measurements) in BiVp vs. controls.
- Duration of Mechanical Ventilation [ Time Frame: From baseline to extubation at 48 hours ]Defined as fulfilling pre-defined, standard eligibility criteria for extubation: adequate gas exchange on an FiO2 of 30% or less, CPAP with pressure support of 10 cm H20, and no evidence of major pulmonary pathology on chest x-ray.
- End Organ Perfusion [ Time Frame: Pre-operative, baseline, and every 24 hours during care and up to 48 hours ]End organ perfusion will be assessed globally and in 3 major organ systems: 1) Kidneys 2) Brain 3) Liver. Globally, blood gases and serum lactate recovery will be used as indicators of organ perfusion.
- QRS Duration [ Time Frame: Pre-operative, baseline, and at study end of 48 hours ]QRS duration is a central measure of electro-mechanical dyssynchrony.QRS duration will be obtained pre-operatively, at baseline (arrival in intensive care unit before pacing) and every 24 hours with and without pacing. Computer generated QRS measurement may be more reliable than manual measurement when QRS is narrow, but all values will be confirmed manually from any lead on the 12-lead ECG.
- Vasoactive-inotropic Score [ Time Frame: Change from baseline of vasoactive-inotropic score to end of care and up to 48 hours ]Doses of vaso-active-inotropic agents at time of CI measurements will be recorded. A total vaso-active inotropic score will be calculated as the inotrope score + 10 x milrinone dose (µg/kg/min) + 10,000 x vasopressin dose (U/kg/min) + 100 x norepinephrine dose (µg/kg/min). The inotrope score is calculated as the dopamine dose (µg/kg/min) + dobutamine dose + 100 x epinephrine dose (µg/kg/min). Maximal vasoactive-inotropic score and change in vasoactive-inotropic score from baseline to study end will be assessed as secondary outcomes.
- Mechanical Dyssynchrony [ Time Frame: Pre-operative, baseline, and at study endat 48 hours ]Mechanical dyssynchrony will be investigated by echo before surgery, at baseline (in ICU before pacing) and at study end (before stopping pacing).
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): NCT02644824
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Mark Friedberg, MD||The Hospital for Sick Children|