Clinical Trials Logo

Clinical Trial Summary

The study aims to recruit 156 (54 Acute Kidney Injury (AKI);102 non-AKI) patients undergoing Cardio pulmonary bypass (CPB) surgery, including those with Chronic Kidney Disease (CKD) and multiple co-morbidities. Urine and blood samples collected pre-operatively and then 0, 3, 6 and 18 hours post-CPB will be stored at -80oC until batch analysed for NGAL using the Abbott and BioPorto assays. AKI - defined as a ≥50% rise in serum creatinine (SCr) over baseline, or the requirement for renal replacement therapy (RRT). SCr will be measured pre-operatively (baseline), then 12 hourly for the first 48 hrs post-CPB and thereafter 24 hourly for 5 days. Clinical data collected will include patient demographics, co-morbidities, drug history, pre-operative renal function, surgery details (type, length, CPB time etc.), length of Intensive treatment unit and hospital stay and post-operative complications. Data will then be analysed comparing the two NGAL tests to find out which is superior, whether it is better to use blood or urine and to define optimal NGAL cut-offs and sample timing for predicting AKI. Both the Abbott and BioPorto assays will subject to a laboratory method evaluation prior to the analysis of any patient specimens in order to verify that their performance is acceptable and meets the manufacturer's claims. This will involve measuring the standard parameters used to assess laboratory assay performance e.g. imprecision (reproducibility), linearity, recovery and method comparison etc.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02733328
Study type Observational
Source The Royal Wolverhampton Hospitals NHS Trust
Contact
Status Completed
Phase
Start date May 2016
Completion date September 7, 2020

See also
  Status Clinical Trial Phase
Completed NCT05422755 - The Clinical Study to Evaluate Immunogenicity of Epodion® in Anemia Associated With CKD Patients
Completed NCT01693029 - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa Phase 3
Recruiting NCT04064827 - A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD) Phase 3
Completed NCT02218099 - A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in Subjects With Renal Impairment and in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease Phase 1/Phase 2
Completed NCT02276742 - Lifestyle Management of CKD in Obese Diabetic Patients N/A
Completed NCT01222234 - Impact of Vitamin D Therapies on Chronic Kidney Disease N/A
Recruiting NCT05106387 - An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive A Kidney Transplant
Completed NCT05373303 - The Clinical Study for Evaluating The Safety And Efficacy Of Epodion® N/A
Completed NCT01247311 - Vitamin D and the Health of Blood Vessels in Kidney Disease N/A
Completed NCT04042350 - Retrospective Analysis Assessing Clinical Risk Factors for Cardiovascular Events and Mortality and Development of a Risk Calculator in Chronic Kidney Disease Stage 5 on Dialysis
Completed NCT02341664 - Patient and Provider Assessment of Lipid Management Registry
Enrolling by invitation NCT06322641 - A Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Nephrologists
Completed NCT05755373 - A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Cardiologists
Completed NCT02678000 - Study of the Safety, Tolerability, and Pharmacokinetics of LHW090 in Patients With Moderately Impaired Renal Function Phase 2
Completed NCT02185911 - Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis N/A
Terminated NCT03226899 - A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment Phase 4
Completed NCT02504294 - A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis Phase 3
Active, not recruiting NCT04094831 - Community-based Screening of Chronic Kidney Disease (CKD) and Measure the Impact of Health Education N/A
Completed NCT01810939 - A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL) Phase 3
Enrolling by invitation NCT06447038 - Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).