Evaluating Novel Biomarkers in Acute Kidney Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Robert Docking, University of Glasgow
ClinicalTrials.gov Identifier:
NCT01573104
First received: April 3, 2012
Last updated: May 26, 2015
Last verified: May 2015
  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
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

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: May 26, 2015
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Glasgow:
Diagnosis
Acute Kidney Injury

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

ClinicalTrials.gov processed this record on July 01, 2015