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MGSO: Magnesium Administration After Cardioplegic Arrest With Del Nido Cardioplegia

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT05298618
Collaborator
(none)
200
Enrollment
1
Location
23.2
Anticipated Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Magnesium Administration After Cardioplegic Arrest With Del Nido Cardioplegia
    Actual Study Start Date :
    Jan 24, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Examine magnesium levels prior to and after cross-clamp. [24 months from start of enrollment.]

      The primary objective of this study is to examine magnesium levels prior to and after cross-clamp.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati

    Investigators

    • Principal Investigator: James Reagor, Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT05298618
    Other Study ID Numbers:
    • 2021-0816
    First Posted:
    Mar 28, 2022
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 28, 2022