Clinical Outcomes Of Modified Del Nido Cardioplegia In Ad... | NCT06744088

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

NCT06744088

Sponsor

Superior University

Status

Active, not recruiting

Last Update Posted

Dec 20, 2024Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Cardiac Events

Interventions

Del Nido cardioplegia

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2024Actual

Primary Completion Date

Jun 1, 2024Actual

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Dec 17, 2024

First Submission Date that Met QC Criteria

Dec 19, 2024

First Posted Date

Dec 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2024

Last Update Posted Date

Dec 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Del Nido cardioplegia	Combination Product	To assess the clinical outcomes of modified Del Nido cardioplegia in cardiac surgeries across different age groups,

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

60 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Peshawar		Peshawar	Khyber Pakhtunkhwa		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided