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Evaluating Novel Biomarkers in Acute Kidney Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01573104
First Posted: April 6, 2012
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Robert Docking, University of Glasgow
  Purpose

The investigators have a new technique of looking at urine to see whether it contains protein fragments that are released by damaged kidneys. These fragments seem to be more accurate than the current blood tests that the investigators use to diagnose renal failure. This technique needs to be validated with a group of patients that have a relatively high incidence of renal failure, cardiopulmonary bypass.

The investigators hypothesise that using novel markers of renal dysfunction will identify patients who go on to develop renal failure earlier, and in a higher number than the standard blood tests.

The investigators aim to collect urine from patients before going onto bypass, and then at Day 1 and Day 2 after bypass. This urine will be analysed for protein fragments, as well as other new markers of renal dysfunction. The investigators will also take blood at baseline and for the first two days in Cardiac Intensive Care, and compare the accuracy of the new tests with the 'gold standard' that is creatinine.


Condition Intervention
Acute Kidney Injury Other: Proteomic assay Other: Blood sampling Other: Biomarker sampling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluating the Utility of Urinary Proteomics and Novel Biomarkers in Acute Kidney Injury

Further study details as provided by Dr Robert Docking, University of Glasgow:

Primary Outcome Measures:
  • Development of acute kidney injury [ Time Frame: Within two days of cardiopulmonary bypass ]
    Development of AKI will be defined by stage 1 of AKIN criteria (ie serum Creatinine >25% of baseline, or oliguria <0.5ml/kg/hr for 6 hours.


Enrollment: 87
Study Start Date: November 2012
Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biomarker group
Patients undergoing CPB having proteomic assays, blood sampling and biomarker assays performed on D0, D1, D2 and D3
Other: Proteomic assay
Urine will be taken for proteomic assay at baseline, day 1 and day 2
Other: Blood sampling
Point of care testing of blood for NGAL/BNP at baseline, day 1 and day 2
Other: Biomarker sampling
Urine will be taken at baseline and day 1, day 2 for evaluation of renal biomarkers at later date

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing elective cardiopulmonary bypass
  • mental capacity
  • able to understand written English

Exclusion Criteria:

  • patient refusal
  • surgical refusal
  • chronic renal replacement therapy
  • emergency procedures
  • peri-operative use of ventricular assist devices
  • pregnancy
  • pre-operative exercise function NYHA IV
  • severe chronic renal failure (eGFR <30ml/min/1.73m2).
  • pregnancy
  Contacts and Locations
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): NCT01573104


Locations
United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom, G81 4DY
Sponsors and Collaborators
Dr Robert Docking
Investigators
Principal Investigator: John Kinsella, MD, FRCA University of Glasgow
  More Information

Responsible Party: Dr Robert Docking, Clinical Research Fellow, University of Glasgow
ClinicalTrials.gov Identifier: NCT01573104     History of Changes
Other Study ID Numbers: RID-001
First Submitted: April 3, 2012
First Posted: April 6, 2012
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Dr Robert Docking, University of Glasgow:
Diagnosis
Acute Kidney Injury

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