Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes (BIOMARKERS)
|ClinicalTrials.gov Identifier: NCT00948116|
Recruitment Status : Unknown
Verified March 2009 by Barts & The London NHS Trust.
Recruitment status was: Recruiting
First Posted : July 29, 2009
Last Update Posted : July 27, 2010
|Condition or disease|
|Diabetes Mellitus Renal Impairment|
Diabetes mellitus is an important risk factor for the development of contrast induced nephropathy (CIN), acting as a 'risk multiplier', amplifying the risk of acute kidney injury in these patients. There are important prognostic implications following the development of CIN and it is associated with a significantly increased mortality at 1 year. Diabetes is a major risk factor for coronary disease and these patients often have significant co−morbidities.
Currently creatinine is used to assess risk but this often lags behind clinical status. There is a pressing need for the development of novel, specific biomarkers to improve the detection and treatment of CIN and improve patient outcome in this high risk population.
This is a single centre,study in diabetic patients already undergoing a planned procedure, that is, a percutaneous coronary intervention (PCI). They are patients who are deemed to have an enhanced risk of contrast induced nephropathy by virtue of their diabetic and renal status, the latter being defined by a reduced eGFR which is a marker of renal disease and is based on the creatinine and characteristics of the patient. No additional interventions that are not part of their routine clinical care will be undertaken in these patients. We will be identifying natural biomarkers by obtaining serum and urine samples from these patients.
From a retrospective audit of the cardiac catheter lab database and a review of the literature we have estimated that a sample size of approximately 250 patients with DM and CKD (eGFR < 60 ml/ml) will be needed. We envisage that that we will encounter at least 50 cases of CIN from this cohort. (based on an expected incidence of CIN between 15−30% in this group). Looking for a study rate difference of at least 25%, for power of 95% and confidence intervals of 95% (with Fleiss correction) we will need at least 204 evaluable patients (to avoid Type 2 error). In view of potential drop−out of 10−15% we therefore intend to recruit 250 patients By using C statistics (Receiver operator curve analysis) we will be able to confirm or otherwise that either a particular biomarker or a combination of several biomarkers within 18 hours of procedure will increase the predictive power of CIN developing 72 hours later.
As part of their normal care patients will arrive in hospital on the morning of their planned PCI. They will at some point during the day undergo their PCI. Blood and urine will be taken just prior to the procedure and then at 2 hours, 4 hours, 8 to 12 hours, pre discharge and 3 days after the PCI.
We will then analyse the samples using ELISA techniques and correlate the biomarkers with creatinine to explore which biomarkers or panel of biomarkers may be able to diagnose contrast induced nephropathy earlier than creatinine can currently.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing Coronary Revascularisation|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||October 2011|
Diabetes mellitus, renal impairment
Patients with both diabetes mellitus and eGFR <60 ml/min
- Development of contrast induced nephropathy (CIN) which will be defined as an increase in Cr of ≥ 44 μmol/l within 72 hours post-procedure. [ Time Frame: up to 72 hours ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948116
|Contact: AKHIL KAPUR||0208 983 email@example.com|
|Contact: KATIE QURESHI||0208 983 firstname.lastname@example.org|
|The London Chest Hospital||Recruiting|
|London, United Kingdom, E2 9JX|
|Contact: AKHIL KAPUR 0208 983 2413 email@example.com|
|Contact: KATIE QURESHI 0208 983 2477 firstname.lastname@example.org|
|Principal Investigator: AKHIL KAPUR|
|Sub-Investigator: KATIE QURESHI|
|Principal Investigator: MAGDI YAQOOB|
|Principal Investigator:||AKHIL KAPUR||CONSULTANT CARDIOLOGIST AND HONORARY SENIOR LECTURER, BARTS AND THE LONDON NHS TRUST|
|Principal Investigator:||KATIE QURESHI||Clinical Research Fellow/Specialist Registrar, Barts and The London NHS Trust|
|Principal Investigator:||MAGDI YAQOOB||PROFESSOR AND CONSULTANT NEPHROLOGIST, HEAD DEPARTMENT OF EXPERIMENTAL MEDICINE AND NEPHROLOGY|