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

An observational study of Acute Kidney Injury and Acute Renal Failure, run by Selayang Hospital at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Kidney Injury, Acute Renal Failure, Kidney Failure, Acute
What is being tested?: No AKI, CA-AKI and HA-AKI
How many people: 170,000 participants
Where: 1 siteMalaysia
Study dates: 1 Nov 2017to 31 Dec 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

Selayang Hospital
Batu Caves, Selangor, 68100

Other trials in Malaysia

About this study

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.

Conditions: Acute Kidney Injury, Acute Renal Failure, Kidney Failure, Acute, Hospital Acquired Condition
Being tested: No AKI, CA-AKI, HA-AKI
Keywords: Acute Kidney Injury, Hospital-acquired Acute Kidney Injury, Community-acquired Acute Kidney Injury, Acute Renal Failure
Medical subject headings: Acute Kidney Injury, Iatrogenic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No AKIOther
Subjects will be allocated into this group if they did not acquire Acute Kidney Injury during admission.
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:
1. 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:
1. 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-AKIOther
HA-AKI is defined by any patient who developed AKI (as per definition below) after 48 hours of hospital admission.
Definition of AKI:
1. 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:
1. 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.

Study groups in NCT03353389
Study group	Role	What they receive
No AKI		Adult admissions without Acute Kidney Injury during their stay Receives: Other: No AKI
CA-AKI		Adult admissions with Acute Kidney Injury diagnosed within 48 hours during their stay (Community-acquired Acute Kidney Injury) Receives: Other: CA-AKI
HA-AKI		Adult admissions with Acute Kidney Injury diagnosed after 48 hours during their stay (Hospital-acquired Acute Kidney Injury) Receives: Other: HA-AKI

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Hospital-acquired Acute Kidney Injury
Incidence of Hospital-acquired Acute Kidney Injury among the adult admissions
Measured: 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
Renal Recovery among adult admissions for Hospital-acquired Acute Kidney Injury
Measured: 90 days after diagnosis of Acute Kidney Injury
In-hospital Mortality from Hospital-acquired Acute Kidney Injury
Mortality rate among adult admissions for Hospital-acquired Acute Kidney Injury
Measured: During admissions to study site with Hospital-acquired Acute Kidney Injury, through study completion (an average of 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201731 Dec 2021

First posted27 Nov 2017
Study start1 Nov 2017
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 170,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03353389
Sponsor's protocol ID: HA-AKI-1
Acronym: HA-AKI-HS
Status last verified: May 2022
First submitted: 18 Nov 2017
Last updated: 19 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Kidney Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Review of Trend in Incidence and Characteristics of Hospital-acquired Acute Kidney Injury in Hospital Selayang
ClinicalTrials.gov ID: NCT03353389
Acronym / sponsor ID: HA-AKI-HS / HA-AKI-1
Conditions: 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
Study type: Observational
Recruitment status: Completed
Enrolment: 170,000 participants (actual)
Lead sponsor: Selayang HospitalOther government
Study start: 1 Nov 2017 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 27 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
No AKI	–	Other: No AKIAdult admissions without Acute Kidney Injury during their stay
CA-AKI	–	Other: CA-AKIAdult admissions with Acute Kidney Injury diagnosed within 48 hours during their stay (Community-acquired Acute Kidney Injury)
HA-AKI	–	Other: HA-AKIAdult admissions with Acute Kidney Injury diagnosed after 48 hours during their stay (Hospital-acquired Acute Kidney Injury)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (5 listed)

Adult admissions to Hospital Selayang from

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No AKISubjects will be allocated into this group if they did not acquire Acute Kidney Injury during admission.	Other	No AKI
CA-AKICA-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.	Other	CA-AKI
HA-AKIHA-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.	Other	HA-AKI

Primary outcome

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

2 secondary outcomes

Renal Recovery from Hospital-acquired Acute Kidney Injury
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
Results publication: PubMed 22890468Khwaja 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.
Results publication: PubMed 23394211Kellum 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.
Results publication: PubMed 23326047Kumar 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.
Results publication: PubMed 28495862Jannot 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.
Results publication: PubMed 28487772Cely 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.
Results publication: PubMed 20338313Swaminathan 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.
Results publication: PubMed 24445744Rewa 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.
Results publication: PubMed 11979336Nash 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.
Results publication: PubMed 6824004Hou 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.
Results publication: PubMed 17314324Ali 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.
Individual participant dataSharing planned: 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.

Related trials for Acute Kidney Injury

Not yet recruiting
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Not yet recruiting
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Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lee Fei Yee, BPharm principal investigator

Clinical Research Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury and Acute Renal Failure, run by Selayang Hospital at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03353389, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.