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NCT Number: NCT06744088

Clinical Outcomes Of Modified Del Nido Cardioplegia In Adult And Pediatric Cardiac Surgery

"Introduction: Modern cardiac surgery prioritizes myocardial protection, incorporating various strategies including cardioplegia to preserve heart function during surgery. The Del Nido (DN) cardioplegia solution, initially for pediatric use, shows promise in adult surgeries due to its longer protection duration and reduced re-dosing needs. However, its efficacy in adults remains under-researched.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiac Events Cardiovascular Diseases

Age range

1 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

About this study

This study aims to evaluate the clinical outcomes of modified Del Nido cardioplegia in adult and pediatric cardiac surgeries, comparing intraoperative and postoperative metrics to provide evidence on its efficacy and safety.

To assess the clinical outcomes of modified Del Nido cardioplegia in cardiac surgeries across different age groups, focusing on myocardial protection, hemodynamic stability, surgical outcomes, recovery, and complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All Pediatric patients with congenital heart diseases.
  • Individuals who are capable of giving their informed permission;
  • Stable patients undergoing surgical procedures that involve cardiopulmonary bypass and cardiac arrest;
  • isolated CABG surgery, or simultaneous CABG;
  • isolated single-valve surgery or multiple value procedures.

Exclusion criteria

  • Previous cardiac surgery
  • Patients with preoperative inotropic pharmacologic support
  • Patients receiving preoperative mechanical circulatory support,
  • Patients with an implanted pacemaker or implantable cardioverter-defibrillator,
  • Patients undergoing cardiac surgical procedures
  • Patients who underwent off-pump or beating heart CABGs
  • Ventilation for the night was scheduled because of severe pulmonary arterial hypertension.
  • mediastinal drain causing a delay in extubation, or the need to reopen for bleeding or tamponade.

Treatment and study plan

Del Nido cardioplegia

Combination Product

To assess the clinical outcomes of modified Del Nido cardioplegia in cardiac surgeries across different age groups,

Primary outcomes

  1. the Bypass time

    Time frame: up to 12 Months

  2. postoperative mortality

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Clinical Outcomes Of Modified Del Nido Cardioplegia In Adult And Pediatric Cardiac Surgery; A Multicentered Cross-Sectional Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

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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