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

Recruiting

• Conditions: Acute Kidney Injury

• Registration Number: NCT03263325
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-28
• Study Start: 2017-10-25
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• less than or equal to 8 years of age
• scheduled for cardiac surgery

Exclusion Criteria

• severe pre-existing renal insufficiency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AKI	within 72 hours after surgery	development of AKI

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States