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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
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 72 hours in infants with EMD following CHD surgery compared to standard care alone.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease (CHD) Other: Biventricular pacing Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
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):

  1. Atrial sensing- right ventricular pacing 10 min.
  2. 5 min no pacing (washout).
  3. Atrial sensing - biventricular pacing 10 min.
  4. 5 min no pacing (washout).
  5. Intrinsic rhythm
  6. 5 min no pacing (washout). Start extended phase pacing according to randomization. Measure hemodynamic variables 10 min after start of pacing.

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. Serum Lactate [ Time Frame: Over 72 hours recorded every 6 hours ]
    Serum lactate over 72 hours, recorded every 6 hours.

  7. 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

  8. Length of stay in CCCU [ Time Frame: Over 72 hours ]
    Length of stay in CCCU (recorded in hours).

  9. Electrical dyssynchrony [ Time Frame: Baseline and 48 hours ]
    Electrical dyssynchrony at 48 hours (QRS duration in msec from 6-lead limb ECG).

  10. 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.



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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • < 4 months of age at time of surgery
  • Surgery for congenital heart disease requiring cardiopulmonary bypass
  • Reparative surgery to achieve biventricular cardiac physiology.
  • Sinus rhythm.

Exclusion Criteria:

  • Isolated atrial septal defect repair.
  • Surgery without cardiopulmonary bypass.
  • Palliative surgery.
  • Single ventricle physiology.
  • Age > 4 months at time of surgery
  • Clinical indication for pacing (e.g. iatrogenic heart block)
  • Arrhythmia
  • Second or third degree heart block.
  • Patient with known bleeding disorder
  • Patient requires ECMO in operating room (eg. unable to wean from cardio-pulmonary bypass or hemodynamic/ respiratory instability that requires ECMO in OR). These patients return from the OR to the ICU on ECMO.

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): NCT02806245


Locations
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Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Mark K Friedberg, MD The Hospital for Sick Children

Publications of Results:
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Responsible Party: Mark Friedberg, Associate Scientist, Staff Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02806245     History of Changes
Other Study ID Numbers: 1000010911
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities