Overview

This trial is active, not recruiting.

Conditions congenital heart disease, acute kidney injury
Sponsor Children's Hospital Medical Center, Cincinnati
Collaborator Thrasher Research Fund
Start date September 2013
End date April 2015
Trial size 74 participants
Trial identifier NCT01966237, 2013-2507

Summary

Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary biomarkers have the ability to detect AKI earlier. Whether early detection of AKI through urinary biomarkers can predict altered drug levels is unknown.

Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting in low blood pressure. Dose adjustments are not currently possible because of the late rise in SCr, and are based on clinical parameters that may lead to clinically relevant over or under-dosing. Thus, this study will address an important knowledge gap being the first to use elevations of AKI biomarker concentrations to anticipate increased milrinone levels.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
AKI defined by an elevation in urinary AKI biomarkers
No AKI defined by normal urinary AKI biomarkers

Primary Outcomes

Measure
Biomarker elevation and milrinone clearance
time frame: By 24 hours

Secondary Outcomes

Measure
Creatinine elevation and milrinone clearance
time frame: by 72 hours

Eligibility Criteria

Male or female participants up to 1 year old.

Inclusion Criteria: - Undergoing cardiothoracic surgery with cardiopulmonary bypass - weight greater than 2500 grams (5 pounds 8 ounces) at the time of surgery - gestational age > 36 weeks - age less < to 1 year - infants with complex congenital heart disease - use of milrinone in the intra-operative and post-operative period. Exclusion Criteria: - Pre-existing kidney disease (structural and functional abnormalities) as determined by the Principal Investigator - use of aminoglycosides within 48 hours of planned surgery - cardiac arrest prior to cardiac surgery - extracorporeal membrane oxygenation prior to cardiac surgery - urinary tract infection prior to surgery - repair of an isolated atrial or ventricular septal defect

Additional Information

Official title USE OF ACUTE KIDNEY INJURY BIOMARKERS TO PREDICT IMPAIRED MILRINONE PHARMACOKINETICS IN CHILDREN FOLLOWING CARDIAC SURGERY
Principal investigator Katja M Gist, DO, MSCS
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.