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Search / Trial NCT03082716

Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery

Launched by KING FAISAL SPECIALIST HOSPITAL & RESEARCH CENTRE, JEDDAH · Mar 12, 2017

Trial Information

Current as of May 08, 2025

Completed

Keywords

Cardioplegia Myocardial Protection Custodiol Htk

ClinConnect Summary

Hypothesis :

Custodial is not inferior to blood cardioplegia in myocardial protection in paediatric cardiac surgery ..

Methodology :

Study design :

Randomized controlled trial

Data collection:

All demographic data ,diagnosis ,procedure(type.CPB time ,crossclamp time) , surgeon and hospital course details .

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 subs...

Gender

ALL

Eligibility 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 .

About King Faisal Specialist Hospital & Research Centre, Jeddah

King Faisal Specialist Hospital & Research Centre (KFSH&RC) in Jeddah is a premier healthcare institution renowned for its commitment to excellence in patient care, medical research, and education. As a leading sponsor of clinical trials, KFSH&RC leverages cutting-edge technology and a multidisciplinary approach to advance medical knowledge and improve treatment outcomes. The institution is dedicated to conducting high-quality research that adheres to international standards, fostering innovation in various fields of medicine while ensuring the highest ethical standards and patient safety. With a robust infrastructure and a team of experienced professionals, KFSH&RC is at the forefront of transforming healthcare through research and clinical excellence.

Locations

Jeddah, Western, Saudi Arabia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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