Review of Trend in Incidence and Characteristics of Hospital-acquired Acute Kidney Injury in Hospital Selayang (HA-AKI-HS)

May 18, 2022 updated by: Selayang Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

170000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor Darul Ehsan
      • Batu Caves, Selangor Darul Ehsan, Malaysia, 68100
        • Selayang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No AKI
Adult admissions without Acute Kidney Injury during their stay
Other: No AKI
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)
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.
HA-AKI
Adult admissions with Acute Kidney Injury diagnosed after 48 hours during their stay (Hospital-acquired Acute Kidney Injury)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hospital-acquired Acute Kidney Injury
Time Frame: During admissions to study site (Year 2001-2002, Year 2006-2007, Year 2011-2012, Year 2016-2017)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Recovery from Hospital-acquired Acute Kidney Injury
Time Frame: 90 days after diagnosis of 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
Time Frame: During admissions to study site with Hospital-acquired Acute Kidney Injury, through study completion (an average of 1 year)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selayang Hospital

Investigators

  • Principal Investigator: Lee Fei Yee, BPharm, Clinical Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

November 18, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (ACTUAL)

November 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA-AKI-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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