Evaluating Novel Biomarkers in Acute Kidney Injury
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|ClinicalTrials.gov Identifier: NCT01573104|
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : May 27, 2015
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 or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Other: Proteomic assay Other: Blood sampling Other: Biomarker sampling||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluating the Utility of Urinary Proteomics and Novel Biomarkers in Acute Kidney Injury|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2015|
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 2Other: Blood sampling
Point of care testing of blood for NGAL/BNP at baseline, day 1 and day 2Other: Biomarker sampling
Urine will be taken at baseline and day 1, day 2 for evaluation of renal biomarkers at later date
- 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.
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
|Golden Jubilee National Hospital|
|Glasgow, United Kingdom, G81 4DY|
|Principal Investigator:||John Kinsella, MD, FRCA||University of Glasgow|