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

NCT ID: NCT06744088

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-28

Study Completion Date

2025-03-01

Brief Summary

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"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

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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.

Conditions

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Cardiac Events

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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Del Nido cardioplegia

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSAHS/Batch-Spring23/007

Identifier Type: -

Identifier Source: org_study_id