An interventional study of AKI risk screening using RenaFAST POCT test kits in Acute Kidney Injury, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Screening
The study aims to perform real-time validation of the RenaFAST kit (a point-of-care test kit that quantifies three urinary proteins) in predicting acute kidney injury(AKI) among patients prescribed drug therapies of nephrotoxic potential. Based on the type and duration of drug therapy, a maximum of 5 time-point urine samples will be collected from consenting patients and a real-time biomarker analysis will be conducted using the RenaFAST kits.
All eligible patients who fulfill the inclusion and exclusion criteria will be approached for consent. The patients with the highest AKI risk (with all 3 urine biomarkers, Clusterin, monocyte chemoattractant protein-1 (MCP1), and Beta-2 microglobulin (ß2MG), above prediction threshold set by the study) will be identified. The nephrology consultants within the research team will perform a medical chart and physical review(where required) of these patients, noting potential actions to be taken in data collection forms. This will help in evaluating if indeed there are perceived interventions that could potentially be delivered in response to early prediction of AKI.
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →National University Hospital, Singapore is the lead sponsor of 451 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
All consenting patients will have a real-time biomarker analysis done at 5 time-points during their course of drug therapy using the renaFAST kits.
Diagnostic Test: AKI risk screening using RenaFAST POCT test kits
Based on the type and duration of drug therapy, a maximum of 5 time-point urine samples will be collected and real-time biomarker measurement will be done using the RenaFAST POCT kits. Additionally, Trefoil factor 3 (TFF3) biomarker levels will also be quantified using developed POCT kits. Patients with all 3 biomarker (Clusterin, MCP1 and ß2MG) levels higher than the study cut-off will be identified as high-risk for AKI. The nephrology consultants within the research team will perform a medical chart and physical review (where required) of these patients, detailing potential actions to be taken in research data collection forms. No actual intervention (other than a patient review) will be performed.
Presence of an Acute kidney injury (AKI) event
AKI will be defined by the minimum stage 1 criterion in accordance to KDIGO AKI criteria: 1. Relative increase in serum creatinine of 1.5 times or higher, versus the baseline. 2. Absolute increase in serum creatinine of \> 26.5 μmol/L within 48 hours. Additionally, for those administered cisplatin, cases of severe hyponatremia needing hospitalization for severe dehydration and intravenous fluid-rescue will also be taken as an outcome measure of clinically-evident kidney injury and renal salt wasting. If the subject meets any one of the above 3 criteria, the patient will be recorded as having suffered an AKI event.
Time frame: Start date of drug therapy till one week post end date of drug therapy
Severity of AKI event
Peak AKI severity will be determined by highest recorded serum creatinine levels of patient.
Time frame: From the date of AKI onset to date of peak AKI
Number of AKI days till recovery
Number of days from the onset of AKI (as per aforementioned AKI criteria) to resolution of AKI (Defined as when serum creatinine levels reach baseline levels or no longer meet the AKI criterion, whichever is earlier)
Time frame: From the date of AKI onset to date of resolution of AKI
Length of stay in hospital
Duration of hospital stay will be determined based on admission and discharge dates of the patient, for the period relevant to study participation.
Time frame: From the date of admission to the date of discharge of patient from hospital, assessed up to 12months from date of consent
Number of patients requiring dialysis treatment for the AKI event
Whether patient required dialysis/CRRT for treatment of AKI event
Time frame: From the date of AKI onset to date of resolution of AKI
Plan to share: No
Start is estimated for Nov 2023; primary completion for Oct 2024, 11 months later.
Of 239 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 44. This study's planned 11 months is below that.
Counting every sponsor, half of 255 studies reached it within 26 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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