Tailored MgSO4 Supplementation to Reduce Complications in Pediatric Heart Surgery

NCT06564376 | Not Yet Recruiting FDA Device

• 1 other identifier: s42qwux9
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Lay Summary This study tests two ways of measuring blood magnesium after heart surgery. Children who need heart surgery may have heart and kidney problems after surgery. The right amount of magnesium in blood reduces this risk. This study will test the best way to measure magnesium. This will let doctors choose the right dose of MgSO4. MgSO4 is a magnesium supplement. Taking MgSO4 after heart surgery helps children. For each child, it is best to personalize MgSO4 dose. This is based on the amount of magnesium in blood. This study will test two ways of personalizing MgSO4 dose. In the blood, there are two kinds of magnesium. Usually, blood magnesium tests measure both forms together. This does not say anything about active magnesium. This study will measure the two forms separately. Then, MgSO4 will be given based on either the active or whole magnesium. Measuring active magnesium is good. Active magnesium levels change faster than total. That means active magnesium tests may better protect children. Also, active magnesium has more of an impact on heart and kidney function. Focusing on the active form will help these organs stay healthy. To test how well the MgSO4 is working, heart and kidneys will be examined. After surgery, certain harmful heart rhythms can occur. The types and number of harmful rhythms will be studied. Kidney problems can also happen after heart surgery. Kidney health will be studied. To help understand how active magnesium works, further tests will be done. These tests will look for evidence of poor health in the cells that make up the heart, kidney, and blood.

Conditions

AKI - Acute Kidney Injury; Arrythmia; Congenital Heart Disease

Keywords

Acute Kidney Injury; Arrhythmias; Congenital heart surgery; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (6)

• Duration from reanimation to sinus rhythm

  48 hours after reanimation

• Time in non-sinus rhythms: within 24h of removing aortic cross-clamp

  first 24 hours after reanimation

• Time in non-sinus rhythms: 24-48h after removing aortic cross-clamp

  24-48 hours after reanimation

• Presence of any arrhythmia

  Defined as any non-sinus rhythm

  48 hours after reanimation

• Urine NGAL concentration

  Sensitive marker of acute kidney injury

  48 hours after reanimation

• Urine Creatinine concentration

  The combination of NGAL/Creatine increases sensitivity marker of acute kidney injury

  48 hours after reanimation

Study Arms (2)

Total magnesium

OTHER

Magnesium dosing based on total Mg blood level

Diagnostic Test: total magnesium

ionized Magnesium

ACTIVE COMPARATOR

Magnesium dosing based upon ionized Mg level

Device: ionized magnesium

Interventions

total magnesium DIAGNOSTIC_TEST

Treatment based on total Magnesium

Total magnesium

ionized magnesium DEVICE

Treatment based on ionized magnesium

ionized Magnesium

Eligibility Criteria

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

You may qualify if:

• Children undergoing cardiac surgery utilizing cardiopulmonary bypass

You may not qualify if:

• Children undergoing cardiac surgery without cardiopulmonary bypass
• Children with Renal disease
• Children with pre-existing arrhythmia
• Children on anti-arrhythmia medication

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Arrhythmias, Cardiac; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David A Rosen, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Rosen, MD

CONTACT

3045984000; rosend@wvumedicine.org

Frank L Casey, MD

CONTACT

3042931017; flcasey@hsc.wvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

US (1)