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NCT03263325 Clinical Trial

Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:
Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03263325
Other study ID # IRB-P00025852
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 25, 2017
Est. completion date August 1, 2023

Study information
Verified date February 2023
Source Boston Children's Hospital
Contact Douglas Atkinson, MD
Phone 617-355-6225
Email Douglas.Atkinson@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute kidney injury (AKI) is common in children after cardiac surgery with a reported incidence of 20-40%. Pediatric AKI has been found to be associated with important short and long-term adverse outcomes. A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies exclusively on elevation of serum creatinine concentration and oliguria. Both of these markers lack sensitivity and specificity, and result in delayed detection of kidney injury. This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary bypass.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date August 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 8 Years
Eligibility Inclusion Criteria: - less than or equal to 8 years of age - scheduled for cardiac surgery Exclusion Criteria: - severe pre-existing renal insufficiency

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Discarded urine sample
Collection of discarded urine during surgery and following surgery

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary AKI development of AKI within 72 hours after surgery
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