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

NCT ID: NCT03263325

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-25

Study Completion Date

2023-08-01

Brief Summary

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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

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Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AKI Group

Patients developing AKI after surgery

Discarded urine sample

Intervention Type OTHER

Collection of discarded urine during surgery and following surgery

No AKI Group

Patients who do not develop AKI after surgery

Discarded urine sample

Intervention Type OTHER

Collection of discarded urine during surgery and following surgery

Interventions

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Discarded urine sample

Collection of discarded urine during surgery and following surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* severe pre-existing renal insufficiency
Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Douglas Atkinson

Cardiac Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas Atkinson, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Douglas Atkinson, MD

Role: CONTACT

617-355-6225

Rachel Bernier, MPH

Role: CONTACT

857-218-5348

Facility Contacts

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Douglas Atkinson, MD

Role: primary

617-355-6225

Other Identifiers

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IRB-P00025852

Identifier Type: -

Identifier Source: org_study_id

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