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

Acute Kidney Injury Clinical Trial

— HA-AKI-HS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353389
• Other study ID #: HA-AKI-1
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Selayang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Hospital Acquired Condition
• Iatrogenic Disease
• Kidney Failure, Acute
• Renal Insufficiency
• Wounds and Injuries

Intervention

Other:
• No AKI
Subjects will be allocated into this group if they did not acquire Acute Kidney Injury during admission.
• 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
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.

Locations

Country	Name	City	State
Malaysia	Selayang Hospital	Batu Caves	Selangor Darul Ehsan

Sponsors (1)

Lead Sponsor	Collaborator
Selayang Hospital

Country where clinical trial is conducted

Malaysia, 

References & Publications (10)

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. Epub 2007 Feb 21. — View Citation

Cely JE, Mendoza EJ, Olivares CR, Sepúlveda OJ, Acosta JS, Barón 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 — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6. — View Citation

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. Review. — View Citation

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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Renal Recovery from Hospital-acquired Acute Kidney Injury	Renal Recovery among adult admissions for Hospital-acquired Acute Kidney Injury	90 days after diagnosis of Acute Kidney Injury
Secondary	In-hospital Mortality from Hospital-acquired Acute Kidney Injury	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)