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| Name | Class |
|---|---|
| Agency for Science, Technology and Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKI risk screening using RenaFAST POCT test kits | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKI risk screening using RenaFAST POCT test kits | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of an Acute kidney injury (AKI) event | AKI will be defined by the minimum stage 1 criterion in accordance to KDIGO AKI criteria:
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. | Start date of drug therapy till one week post end date of drug therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of AKI event | Peak AKI severity will be determined by highest recorded serum creatinine levels of patient. | From the date of AKI onset to date of peak AKI |
| Number of AKI days till recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Horng-Ruey Dr Chua | Contact | 67722544 | horng_ruey_chua@nuhs.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Horng-Ruey Dr Chua | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31296157 | Background | Da Y, Akalya K, Murali T, Vathsala A, Tan CS, Low S, Lim HN, Teo BW, Lau T, Ong L, Chua HR. Serial Quantification of Urinary Protein Biomarkers to Predict Drug-induced Acute Kidney Injury. Curr Drug Metab. 2019;20(8):656-664. doi: 10.2174/1389200220666190711114504. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Single arm design. All eligible and consenting patients will have their time-point urine samples collected and biomarker levels measured.
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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)
| 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. | 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 | From the date of AKI onset to date of resolution of AKI |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |