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

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

"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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiac Events
• Intervention / Treatment: Combination product: Del Nido cardioplegia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan
      • Peshawar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the Bypass time	up to 12 Months
postoperative mortality	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: MSAHS/Batch-Spring23/007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No