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NCT Number: NCT03263325

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

Up to 8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • severe pre-existing renal insufficiency

Treatment and study plan

Discarded urine sample

Other

Collection of discarded urine during surgery and following surgery

Primary outcomes

  1. AKI

    Time frame: within 72 hours after surgery

    development of AKI

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2027
First posted
Aug 28, 2017
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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