Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Mark Friedberg, The Hospital for Sick Children

Brief Summary:
Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased and emphasis has shifted to post-operative morbidity and recovery. Children with CHD undergoing surgery with CPB can experience well-characterized post-operative cardiac dysfunction. When severe, patients can develop clinically important low cardiac output syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which affect the strength of the heart's muscular contractions. These are used to maintain adequate blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to myocardial function and may increase risk for post-operative arrhythmia and impair post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2). In combination with the increased VO2 associated with CPB-induced systemic inflammatory response patients can develop a critical mismatch between oxygen supply and demand, essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic stability without increased VO2 are beneficial. This study will test whether BiVp, a specialized yet simple pacing technique, can improve post-operative CI and recovery in infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes that Continuous BiVp increases the mean change in CI from baseline to 48 hours in infants with EMD following CHD surgery compared to standard care alone.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease (CHD) Device: Biventricular Pacing (BiVp) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants 0-1 year with Congenital Heart Disease
  • Patients with functionally univentricular heart disease
  • Informed consent

Exclusion Criteria:

  • Infants <2.5 kg at time of surgery
  • Infants with biventricular heart disease
  • Informed consent is not given

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Layout table for investigator information
Principal Investigator: Mark Friedberg, MD The Hospital for Sick Children

Layout table for additonal information
Responsible Party: Mark Friedberg, Staff Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02644824     History of Changes
Other Study ID Numbers: 1000032246
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Mark Friedberg, The Hospital for Sick Children:
Congenital Heart Disease (CHD)
Cardiopulmonary Bypass (CPB)
Cardiac Index
Hemodynamics
Pediatrics

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities