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Completed

NCT Number: NCT03353389

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No AKI

Other

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

CA-AKI

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Selayang Hospital

Other Gov

Registry information

Acronym: HA-AKI-HS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2017
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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