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

Active, not recruiting

• Conditions: Cardiac Events

• Registration Number: NCT06744088
• Lead Sponsor: Superior University

Brief Summary

"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.

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 Timeline

• Study Start: 2024-02-28
• Primary Completion: 2024-06-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the Bypass time	up to 12 Months
postoperative mortality	12 Months

Trial Locations

Locations (1)

Peshawar; 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan