Biventricular Pacing in Children After Surgery for Congenital Heart Disease

NCT02806245 | Completed

• 1 other identifier: 1000010911
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease (CHD)

Keywords

Congenital Heart Disease (CHD); Cardiopulmonary Bypass (CPB); Cardiac Index; Hemodynamics; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Change in mean cardiac index

  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.

  Baseline to 72 hours

Secondary Outcomes (10)

• Composite clinical score

  Baseline to 72 hours

• Oxygen consumption

  Every hour for 1st 24 hrs and then every 6hours

• Intracardiac pressures (RA, LA, CVP, PA)

  Every hour for the 1st 24 hours, then every 6 hours until lines removed

• Mean inotrope score

  every hour for the 1st 24 hours, then every 6 hours

• Mean airway pressure

  every hour for the 1st 24 hours, then every 6 hours

Study Arms (2)

Biventricular pacing

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Biventricular pacing OTHER

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.

Biventricular pacing

Eligibility Criteria

• Age: 1 Day - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \< 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

• Friedberg MK, Schwartz SM, Zhang H, Chiu-Man C, Manlhiot C, Ilina MV, Arsdell GV, Kirsh JA, McCrindle BW, Stephenson EA. Hemodynamic effects of sustained postoperative cardiac resynchronization therapy in infants after repair of congenital heart disease: Results of a randomized clinical trial. Heart Rhythm. 2017 Feb;14(2):240-247. doi: 10.1016/j.hrthm.2016.09.025. Epub 2016 Sep 26.

  PMID: 27687644 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Mark K Friedberg, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist, Staff Cardiologist

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 20, 2016
• Study Start: December 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

CA (1)