NCT03229980

Brief Summary

The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of congenital heart disease encourage us to discuss problems that occur during this surgery especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI) as a result of cessation and re-initiation of coronary artery circulation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2018

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2018

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

July 23, 2017

Last Update Submit

May 9, 2018

Conditions

Cardioplegia

Keywords

myocardial protectionpotassium cardioplegiatropininCustodiol

Outcome Measures

Primary Outcomes (1)

  • Cardiac rhythm on return

    Sinus rhythm or Ventricular Fibrillation: DC will be used or not and if used how much joules and how many times.

    within the first 24 hours

Secondary Outcomes (5)

  • The inotropic score

    within one month

  • Cardiac dysrhythmias

    within the first week

  • blood pressure

    within the first 24 hours

  • transthoracic echocardiography (TTE) changes

    within the first week

  • Troponin I levels

    within the first 24 hours

Study Arms (2)

Group L

ACTIVE COMPARATOR

Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg The content of cardioplegic solution will be (K+, 10mmol/L) lidocaine 50 mg/L, magnesium sulphate 1 gm/L,dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery. Cardioplegic infusion duration will be infused over 300s.

Drug: Cold blood cardioplegia (large volume)

Group S

ACTIVE COMPARATOR

Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg The content of cardioplegic solution will be (K+, 30mmol/L) lidocaine 150 mg/L, magnesium sulphate 3 gm/L, dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery.

Drug: Cold blood cardioplegia (small volume)

Interventions

Cold blood cardioplegia (large volume)DRUG

Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg

Group L
Cold blood cardioplegia (small volume)DRUG

Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg

Group S

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes.
  • Hemodynamic stability.

You may not qualify if:

  • Previous cardiac surgery.
  • Urgent or emergent cases.
  • Any known allergies to components of either cardioplegia solutions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

Study Officials

  • Sayed k Abd-Elshafy, MD

    Associate profossor of anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profossor of Anesthesiology

Study Record Dates

First Submitted

July 23, 2017

First Posted

July 26, 2017

Study Start

August 10, 2017

Primary Completion

April 3, 2018

Study Completion

April 28, 2018

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

EG(1)