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OpenTrials
Completed

NCT Number: NCT03229980

Pediatric Myocardial Protection With Potassium Cardioplegia

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

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Key information

Conditions

Cardioplegia

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Egypt

About this study

After approval of the local ethics committee of Assiut University and obtaining written informed consent from parents or guardians of all patients, 60 patients with congenital heart disease will be included. Patients will be randomly allocated into three groups

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

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

Primary outcomes

  1. Cardiac rhythm on return

    Time frame: within the first 24 hours

    Sinus rhythm or Ventricular Fibrillation:

    DC will be used or not and if used how much joules and how many times.

Secondary outcomes

  1. The inotropic score

    Time frame: within one month

    1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. (i.e. 1 point is assigned for each 10 ng/kg/min of epinephrine, norepinephrine, and phenylephrine.

  2. Cardiac dysrhythmias

    Time frame: within the first week

    Cardiac dysrhythmias during intensive care unit stay

  3. blood pressure

    Time frame: within the first 24 hours

    blood pressure

  4. transthoracic echocardiography (TTE) changes

    Time frame: within the first week

    Changes in ejection fraction by TTE

  5. Troponin I levels

    Time frame: within the first 24 hours

    We will obtain blood samples for troponin I levels (as a marker of myocardial ischemia) pre-CBP, 6, 12 and 24 hours after the surgery.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Pediatric Myocardial Protection; Large Volume Potassium Cardioplegia Advantageous Over Small Volume Potassium Cardioplegia: Where do we Stand?

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2017
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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