Clinical trial NCT03353389: Review of Trend in Incidence and Characteristics of Hospital-acquired Acute Kidney Injury in Hospital Selayang
Official title: Review of Trend in Incidence and Characteristics of Hospital-acquired Acute Kidney Injury in Hospital Selayang
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Acute Renal Failure
Kidney Failure, Acute
Hospital Acquired Condition
Keywords: Acute Kidney Injury
Hospital-acquired Acute Kidney Injury
Community-acquired Acute Kidney Injury
Acute Renal Failure
Lead sponsor: Selayang Hospital
Sponsor class: OTHER_GOV
First posted: 2017-11-27
Enrollment: 170000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult admissions to Hospital Selayang from

* 1st July 2001 to 30th June 2002
* 1st July 2006 to 30th June 2007
* 1st July 2011 to 30th June 2012
* 1st July 2016 to 30th June 2017

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult admissions to Hospital Selayang from

  * 1st July 2001 to 30th June 2002
  * 1st July 2006 to 30th June 2007
  * 1st July 2011 to 30th June 2012
  * 1st July 2016 to 30th June 2017

Exclusion Criteria:

* End Stage Renal Failure and on Renal Replacement Therapy (Hemodialysis, peritoneal dialysis or Renal Transplant)

Primary outcomes:
measure: Incidence of Hospital-acquired Acute Kidney Injury
timeFrame: During admissions to study site (Year 2001-2002, Year 2006-2007, Year 2011-2012, Year 2016-2017)
Secondary outcomes:
measure: Renal Recovery from Hospital-acquired Acute Kidney Injury
timeFrame: 90 days after diagnosis of Acute Kidney Injury
measure: In-hospital Mortality from Hospital-acquired Acute Kidney Injury
timeFrame: During admissions to study site with Hospital-acquired Acute Kidney Injury, through study completion (an average of 1 year)
Other outcomes:
Locations:
city: Batu Caves
country: Malaysia
facility: Selayang Hospital
state: Selangor Darul Ehsan
Study officials:
affiliation: Clinical Research Centre
name: Lee Fei Yee, BPharm
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.