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Evaluating Novel Biomarkers in Acute Kidney Injury

This study is not yet open for participant recruitment.
Verified April 2012 by University of Glasgow
Sponsor:
Information provided by (Responsible Party):
Dr Robert Docking, University of Glasgow
ClinicalTrials.gov Identifier:
NCT01573104
First received: April 3, 2012
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  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: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluating the Utility of Urinary Proteomics and Novel Biomarkers in Acute Kidney Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • Development of acute kidney injury [ Time Frame: Within two days of cardiopulmonary bypass ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573104

Contacts
Contact: Robert I Docking, MBChB, FRCA 447717824350 robert.iain.docking@gmail.com
Contact: John Kinsella, MD, FRCA 4411412114625 john.kinsella@glasgow.ac.uk

Locations
United Kingdom
Golden Jubilee National Hospital Not yet recruiting
Glasgow, United Kingdom, G81 4DY
Contact: Isma Quasim, MBChB, FRCA     44141 951 5000     isma.quasim@gjnh.scot.nhs.uk    
Sub-Investigator: Robert Docking, MBChB, FRCA            
Principal Investigator: Isma Quasim, MBChB, FRCA            
Sponsors and Collaborators
Dr Robert Docking
Investigators
Principal Investigator: John Kinsella, MD, FRCA University of Glasgow
  More Information

No publications provided

Responsible Party: Dr Robert Docking, Clinical Research Fellow, University of Glasgow
ClinicalTrials.gov Identifier: NCT01573104     History of Changes
Other Study ID Numbers: RID-001
Study First Received: April 3, 2012
Last Updated: April 4, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Glasgow:
Diagnosis
Acute Kidney Injury

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

ClinicalTrials.gov processed this record on May 23, 2013