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Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT03082716
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Centre, Jeddah

Brief Summary:
Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial preservation and minimise myocardial swelling ,while providing a motionless and bloodless field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is thought to be more time consuming since it is given with interrupted doses, . Even when advancement has came along the field of myocardial protection and cardioplegia solutions with the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in 1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and less time consuming . Many Surgeons haven't change their practice possibly due to paucity of studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting reports regarding the superiority of different cardioplegia solution.The investigators aim to provide evidence that will help paediatric cardiac surgeons to choose the optimal solution for their practice .

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Drug: Custodiol Solution Drug: Blood cardioplegia Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomisation :

Computer generated randomisation into two groups based on cardioplegia solution .

if randomised to blood patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.

if randomised to custodial patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Blinding :

Surgeons will know the type of cardioplegia in the OR while other assessor will be blinded .

Primary Purpose: Other
Official Title: Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery
Actual Study Start Date : September 19, 2016
Estimated Primary Completion Date : December 19, 2019
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: blood cardioplegia group
patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.
Drug: Blood cardioplegia
After cross clamping patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.

Experimental: custodiol group
patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.
Drug: Custodiol Solution
After cross clamping patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.
Other Name: htk




Primary Outcome Measures :
  1. Mortality (yes/no) [ Time Frame: up to 30 days ]
    Death of all causes

  2. ICU stay (days) [ Time Frame: up to 90 days (length of ICU stay required after the operative procedure recorded by days until discharge or death) ]
    length of ICU stay

  3. Arrhythmia (yes/no) [ Time Frame: up to 48 hours ]
    post operative arrythmia that required intervention


Secondary Outcome Measures :
  1. length of stay (days) [ Time Frame: up to 90 days (length of the hospital stay required since admission recorded by days until discharge or death ) ]
  2. length of mechanical ventilation (hours) [ Time Frame: up to 5 days ]
  3. myocardial biomarkers [ Time Frame: up to 5 days ]
    (troponin and CKMB) measured (preoperatively,postoperatively 6h,24h,48h,)

  4. Subjective ventricular function (normal,mildly depressed ,moderately depressed ,moderately-severe depressed ,severly depressed ) [ Time Frame: up to 24 hours ]
    assessed by a cardiologist subjective assessment of the echocardiographically (preoperative ,immediate post repair ,24h post operative )

  5. Ejection fraction (percentage) [ Time Frame: up to 24 hours ]
    assessed by echocardiography (preoperative ,immediate post repair ,24h post operative )

  6. ECMO support (yes/no) [ Time Frame: intraoperative ]
  7. vasoactive inotropic score ( low or high) [ Time Frame: up to 48 hour ]

    Vasoactive Inotropic score : (all doses of inotropes recorded hourly during 48 h)

    Dopamine dose (μg/kg/min) + Dobutamine dose (μg/kg/min) +100 × epinephrine dose (μg/kg/min)+ 10 X Milrinone dose (μg/kg/min) +10,000 × Vasopressin dose (U/kg/min) + 100 × Norepinephrine dose (μg/kg/min)

    calculated hourly for 48 hours and added than divided by 48 to give the score . if maximum score < 20 its low VIS and if maximum score ≥ 20 its a high VIS




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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All paediatric patients referred to our hospital which will undergo open cardiac repair with cardiopulmonary bypass and cardioplegic arrest .

Exclusion Criteria:

  • All emergency procedure( require immediate surgery)
  • Cases that don't require use of cardioplegia .

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): NCT03082716


Locations
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Saudi Arabia
King Faisal Specialist Hospital and Research Centre Recruiting
Jeddah, Western, Saudi Arabia, 40047
Contact: Bayan Alshaikh, MBBS    00966502088088    b_al-shaikh@hotmail.com   
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Centre, Jeddah

Publications of Results:
Other Publications:
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Responsible Party: King Faisal Specialist Hospital & Research Centre, Jeddah
ClinicalTrials.gov Identifier: NCT03082716     History of Changes
Other Study ID Numbers: IRB 2016-08 Custodiol Study
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by King Faisal Specialist Hospital & Research Centre, Jeddah:
cardioplegia
myocardial protection
custodiol
htk

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases