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

NCT06744088 | Active Not Recruiting DMC

• 1 other identifier: MSAHS/Batch-Spring23/007
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Events

Outcome Measures

Primary Outcomes (2)

• the Bypass time

  up to 12 Months

• postoperative mortality

  12 Months

Interventions

Del Nido cardioplegia COMBINATION_PRODUCT

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

Eligibility Criteria

• Age: 1 Year - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Del Nido cardioplegia solution

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: February 28, 2024
• Primary Completion: June 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)