Magnesium Administration After Cardioplegic Arrest With Del Nido Cardioplegia

NCT ID: NCT05298618

Last Updated: 2024-05-03

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

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-24

Study Completion Date

2024-02-15

Brief Summary

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The cardioplegia solution of choice in many pediatric cardiac congenital programs is the del Nido solution. While many cardioplegia solutions provide diastolic arrest, del Nido provides a longer period of time between doses of cardioplegia. Many of the other cardioplegia solutions do not incorporate magnesium into the constituents, but del Nido does. Routine practice at CCHMC is to dose 25 mg/kg magnesium upon removal of the heart cross-clamp to protect against hypomagnesemia and associated arrhythmias. However, with the incorporation of magnesium in the del Nido solution, it may not be necessary to administer magnesium post cross-clamp and it could in fact be detrimental if the magnesium level is too high. This observational study will examine the magnesium levels prior to and after cross-clamp removal under our current process. The magnesium levels measured after the administration of del Nido cardioplegia and prior to cross-clamp removal will help inform our current practice.

Detailed Description

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Conditions

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Del Nido Cardioplegia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

All patients undergoing CPB with dNC cardioplegic arrest shall have two magnesium levels measured. The first sample shall be taken prior to magnesium administration and within 30 minutes of cross-clamp removal. The second sample will be drawn 10 +/- 5 minutes after cross-clamp removal and magnesium administration. Magnesium levels will be analyzed and compared against normally expected values.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing cardiac surgery requiring CPB and cardioplegic arrest with del Nido cardioplegia solution.
* Patients planned to receive post cross-clamp dose of 25 mg/kg magnesium sulfate.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Reagor

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2021-0816

Identifier Type: -

Identifier Source: org_study_id

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