NCT03353389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

4.2 years

First QC Date

November 18, 2017

Last Update Submit

May 18, 2022

Conditions

Acute Kidney InjuryAcute Renal FailureKidney Failure, AcuteHospital Acquired Condition

Keywords

Acute Kidney InjuryHospital-acquired Acute Kidney InjuryCommunity-acquired Acute Kidney InjuryAcute Renal Failure

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Renal Recovery from Hospital-acquired Acute Kidney Injury

    90 days after diagnosis of Acute Kidney Injury

  • In-hospital Mortality from Hospital-acquired Acute Kidney Injury

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

Study Arms (3)

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

No AKIOTHER

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

No AKI
CA-AKIOTHER

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.

CA-AKI
HA-AKIOTHER

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.

HA-AKI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Adult admissions to Hospital Selayang from
  • st July 2001 to 30th June 2002
  • st July 2006 to 30th June 2007
  • st July 2011 to 30th June 2012
  • st July 2016 to 30th June 2017

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selayang Hospital

Batu Caves, Selangor, 68100, Malaysia

Location

Related Publications (10)

  • 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.

    PMID: 22890468RESULT

  • 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.

    PMID: 23394211RESULT

  • 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.

    PMID: 23326047RESULT

  • 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.

    PMID: 28495862RESULT

  • 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.

    PMID: 28487772RESULT

  • 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.

    PMID: 20338313RESULT

  • 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.

    PMID: 24445744RESULT

  • 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.

    PMID: 11979336RESULT

  • 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.

    PMID: 6824004RESULT

  • 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.

    PMID: 17314324RESULT

MeSH Terms

Conditions

Acute Kidney InjuryIatrogenic Disease

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lee Fei Yee, BPharm

    Clinical Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2017

First Posted

November 27, 2017

Study Start

November 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

MY(1)