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This retrospective cohort study aims to investigate the incidence, risk factors and outcomes of Hospital-acquired Acute Kidney Injury in Hospital Selayang, a tertiary hospital at Malaysia, over 15 years.
This is a retrospective cohort study involving 5-yearly trend from 2002 to 2017 for analysis. Laboratory serum creatinine (SCr) results of all patients admitted during study period will be retrieved from the hospital Laboratory Information System. A preliminary screening list will be generated by using STATA program from the SCr results. The nephrologist will then determine HA-AKI and CA-AKI as per inclusion and exclusion criteria. Data collectors will collect all relevant data from these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No AKI | Adult admissions without Acute Kidney Injury during their stay |
| |
| CA-AKI | Adult admissions with Acute Kidney Injury diagnosed within 48 hours during their stay (Community-acquired Acute Kidney Injury) |
| |
| HA-AKI | Adult admissions with Acute Kidney Injury diagnosed after 48 hours during their stay (Hospital-acquired Acute Kidney Injury) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No AKI | Other | Subjects will be allocated into this group if they did not acquire Acute Kidney Injury during admission. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hospital-acquired Acute Kidney Injury | Incidence of Hospital-acquired Acute Kidney Injury among the adult admissions | During admissions to study site (Year 2001-2002, Year 2006-2007, Year 2011-2012, Year 2016-2017) |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Recovery from Hospital-acquired Acute Kidney Injury | Renal Recovery among adult admissions for Hospital-acquired Acute Kidney Injury | 90 days after diagnosis of Acute Kidney Injury |
| In-hospital Mortality from Hospital-acquired Acute Kidney Injury |
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Inclusion Criteria:
Adult admissions to Hospital Selayang from
Exclusion Criteria:
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Adult admissions to Hospital Selayang from
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| Name | Affiliation | Role |
|---|---|---|
| Lee Fei Yee, BPharm | Clinical Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Selayang Hospital | Batu Caves | Selangor | 68100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22890468 | Result | Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available. | |
| 23394211 | Result | Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454. |
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Subject's names will be kept on a password-protected database and will be linked only with a study identification number for this research. The identification number instead of patient identifiers will be used on subject data sheets. All data will be entered into a computer that is password protected. On completion of study, data in the computer will be copied to CDs and the data in the computer erased. CDs and any hardcopy data will be stored in a locked office of the investigators and maintained for a minimum of three years after the completion of the study. The CDs and data will be destroyed after that period of storage. No personal information will be disclosed and subjects will not be identified when the findings of the survey are published.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2017 | Nov 19, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D007049 | Iatrogenic Disease |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| CA-AKI | Other | CA-AKI is defined by any patient who developed AKI (as per definition below) within 48 hours of hospital admission. Definition of AKI: i. An increase in serum creatinine of 0.3 mg/dl (26.5 μmol/l) within 48 hours OR ii. An increase in serum creatinine to more or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days Definition for baseline creatinine: i. The baseline creatinine level is defined as the creatinine level at or within 7 days before the hospital admission, OR ii. at the hospital admission OR iii. the lowest creatinine (excluding the post dialysis creatinine if dialysis is initiated) during the index hospitalisation for those whose baseline creatinine were unknown. |
|
| HA-AKI | Other | HA-AKI is defined by any patient who developed AKI (as per definition below) after 48 hours of hospital admission. Definition of AKI: i. An increase in serum creatinine of 0.3 mg/dl (26.5 μmol/l) within 48 hours OR ii. An increase in serum creatinine to more or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days Definition for baseline creatinine: i. The baseline creatinine level is defined as the creatinine level at or within 7 days before the hospital admission, OR ii. at the hospital admission OR iii. the lowest creatinine (excluding the post dialysis creatinine if dialysis is initiated) during the index hospitalisation for those whose baseline creatinine were unknown. |
|
Mortality rate among adult admissions for Hospital-acquired Acute Kidney Injury |
| During admissions to study site with Hospital-acquired Acute Kidney Injury, through study completion (an average of 1 year) |
| 23326047 | Result | Kumar S, Raina S, Vikrant S, Patial RK. Spectrum of acute kidney injury in the Himalayan region. Indian J Nephrol. 2012 Sep;22(5):363-6. doi: 10.4103/0971-4065.103914. |
| 28495862 | Result | Jannot AS, Burgun A, Thervet E, Pallet N. The Diagnosis-Wide Landscape of Hospital-Acquired AKI. Clin J Am Soc Nephrol. 2017 Jun 7;12(6):874-884. doi: 10.2215/CJN.10981016. Epub 2017 May 11. |
| 28487772 | Result | Cely JE, Mendoza EJ, Olivares CR, Sepulveda OJ, Acosta JS, Baron RA, Diaztagle JJ. Incidence and Risk Factors for Early Acute Kidney Injury in Nonsurgical Patients: A Cohort Study. Int J Nephrol. 2017;2017:5241482. doi: 10.1155/2017/5241482. Epub 2017 Apr 11. |
| 20338313 | Result | Swaminathan M, Hudson CC, Phillips-Bute BG, Patel UD, Mathew JP, Newman MF, Milano CA, Shaw AD, Stafford-Smith M. Impact of early renal recovery on survival after cardiac surgery-associated acute kidney injury. Ann Thorac Surg. 2010 Apr;89(4):1098-104. doi: 10.1016/j.athoracsur.2009.12.018. |
| 24445744 | Result | Rewa O, Bagshaw SM. Acute kidney injury-epidemiology, outcomes and economics. Nat Rev Nephrol. 2014 Apr;10(4):193-207. doi: 10.1038/nrneph.2013.282. Epub 2014 Jan 21. |
| 11979336 | Result | Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6. doi: 10.1053/ajkd.2002.32766. |
| 6824004 | Result | Hou SH, Bushinsky DA, Wish JB, Cohen JJ, Harrington JT. Hospital-acquired renal insufficiency: a prospective study. Am J Med. 1983 Feb;74(2):243-8. doi: 10.1016/0002-9343(83)90618-6. |
| 17314324 | Result | Ali T, Khan I, Simpson W, Prescott G, Townend J, Smith W, Macleod A. Incidence and outcomes in acute kidney injury: a comprehensive population-based study. J Am Soc Nephrol. 2007 Apr;18(4):1292-8. doi: 10.1681/ASN.2006070756. Epub 2007 Feb 21. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |