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CompletedNCT03353389HA-AKI-HSUpdated May 19, 2022

Review of Trend in Incidence and Characteristics of Hospital-acquired Acute Kidney Injury in Hospital Selayang

An observational study in Acute Kidney Injury, Acute Renal Failure and Kidney Failure, Acute, sponsored by Selayang Hospital. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-19.

Sponsored by Selayang Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
170,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's enrollment of 170,000 is above the median of 160 across 814 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Selayang Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • End Stage Renal Failure and on Renal Replacement Therapy (Hemodialysis, peritoneal dialysis or Renal Transplant)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
170,000 participants (actual)
Patient registry
No

Groups and cohorts

  • No AKI

    Adult admissions without Acute Kidney Injury during their stay

    Other: No AKI

  • CA-AKI

    Adult admissions with Acute Kidney Injury diagnosed within 48 hours during their stay (Community-acquired Acute Kidney Injury)

    Other: CA-AKI

  • HA-AKI

    Adult admissions with Acute Kidney Injury diagnosed after 48 hours during their stay (Hospital-acquired Acute Kidney Injury)

    Other: HA-AKI

Interventions

  • OtherNo AKI

    Subjects will be allocated into this group if they did not acquire Acute Kidney Injury during admission.

  • OtherCA-AKI

    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.

  • OtherHA-AKI

    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.

06

What researchers measure

Primary outcomes

  1. Incidence of Hospital-acquired Acute Kidney Injury

    Incidence of Hospital-acquired Acute Kidney Injury among the adult admissions

    Time frame: During admissions to study site (Year 2001-2002, Year 2006-2007, Year 2011-2012, Year 2016-2017)

Secondary outcomes

  1. Renal Recovery from Hospital-acquired Acute Kidney Injury

    Renal Recovery among adult admissions for Hospital-acquired Acute Kidney Injury

    Time frame: 90 days after diagnosis of Acute Kidney Injury

  2. In-hospital Mortality from Hospital-acquired Acute Kidney Injury

    Mortality rate among adult admissions for Hospital-acquired Acute Kidney Injury

    Time frame: During admissions to study site with Hospital-acquired Acute Kidney Injury, through study completion (an average of 1 year)

07

Study locations

1 site
  • Selayang Hospital
    Batu Caves, Selangor Darul Ehsan 68100, Malaysia
08

References and documents

Publications

  • 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. PubMed 22890468 ↗
  • 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. PubMed 23394211 ↗
  • 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. PubMed 23326047 ↗
  • 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. PubMed 28495862 ↗
  • 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. PubMed 28487772 ↗
  • 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. PubMed 20338313 ↗
  • 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. PubMed 24445744 ↗
  • 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. PubMed 11979336 ↗
  • 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. PubMed 6824004 ↗
  • 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. PubMed 17314324 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Dec 2021, 49 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2017
First posted
Nov 27, 2017
StartActual
Nov 1, 2017
Primary completionActual
Dec 31, 2021
CompletionActual
Dec 31, 2021
Last update
May 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03353389
Lead sponsor
Selayang Hospital
Responsible party
Sponsor
First posted
Nov 27, 2017
Start date
Nov 1, 2017
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
May 19, 2022

Study contacts

Lee Fei Yee, BPharm
principal investigator · Clinical Research Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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