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

NCT ID: NCT03353389

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Kidney Injury Acute Renal Failure Kidney Failure, Acute Hospital Acquired Condition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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No AKI

Adult admissions without Acute Kidney Injury during their stay

No AKI

Intervention Type OTHER

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

CA-AKI

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

CA-AKI

Intervention Type 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

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

HA-AKI

Intervention Type 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.

Interventions

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No AKI

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

Intervention Type OTHER

CA-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.

Intervention Type OTHER

HA-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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selayang Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lee Fei Yee, BPharm

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Centre

Locations

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Selayang Hospital

Batu Caves, Selangor, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type RESULT
PMID: 22890468 (View on PubMed)

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.

Reference Type RESULT
PMID: 23394211 (View on PubMed)

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.

Reference Type RESULT
PMID: 23326047 (View on PubMed)

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.

Reference Type RESULT
PMID: 28495862 (View on PubMed)

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.

Reference Type RESULT
PMID: 28487772 (View on PubMed)

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.

Reference Type RESULT
PMID: 20338313 (View on PubMed)

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.

Reference Type RESULT
PMID: 24445744 (View on PubMed)

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.

Reference Type RESULT
PMID: 11979336 (View on PubMed)

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.

Reference Type RESULT
PMID: 6824004 (View on PubMed)

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.

Reference Type RESULT
PMID: 17314324 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HA-AKI-1

Identifier Type: -

Identifier Source: org_study_id

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