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Trial record 25 of 221 for:    Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

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

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ClinicalTrials.gov Identifier: NCT03263325
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas Atkinson, 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.


Condition or disease Intervention/treatment
Acute Kidney Injury Other: Discarded urine sample

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
AKI Group
Patients developing AKI after surgery
Other: Discarded urine sample
Collection of discarded urine during surgery and following surgery

No AKI Group
Patients who do not develop AKI after surgery
Other: Discarded urine sample
Collection of discarded urine during surgery and following surgery




Primary Outcome Measures :
  1. AKI [ Time Frame: within 72 hours after surgery ]
    development of AKI


Biospecimen Retention:   Samples Without DNA
Urine Samples


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children ≤ 8 years of age having cardiac surgery with cardiopulmonary bypass
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe pre-existing renal insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263325


Contacts
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Contact: Douglas Atkinson, MD 617-355-6225 Douglas.Atkinson@childrens.harvard.edu
Contact: Rachel Bernier, MPH 857-218-5348 Rachel.Bernier@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Douglas Atkinson, MD    617-355-6225    douglas.atkinson@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Douglas Atkinson, MD Boston Children’s Hospital

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Responsible Party: Douglas Atkinson, Cardiac Anesthesiologist, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03263325     History of Changes
Other Study ID Numbers: IRB-P00025852
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases