NCT03263325

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Oct 2017Feb 2027

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

5.7 years

First QC Date

August 24, 2017

Last Update Submit

May 17, 2026

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • AKI

    development of AKI

    within 72 hours after surgery

Study Arms (2)

AKI Group

Patients developing AKI after surgery

Other: Discarded urine sample

No AKI Group

Patients who do not develop AKI after surgery

Other: Discarded urine sample

Interventions

Discarded urine sampleOTHER

Collection of discarded urine during surgery and following surgery

AKI GroupNo AKI Group

Eligibility Criteria

AgeUp to 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children ≤ 8 years of age having cardiac surgery with cardiopulmonary bypass

You may qualify if:

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

You may not qualify if:

  • severe pre-existing renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Samples

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Douglas Atkinson, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiac Anesthesiologist

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

October 25, 2017

Primary Completion

June 28, 2023

Study Completion (Estimated)

February 1, 2027

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)