Long-term Survival and Renal Outcomes in Critically Ill Patients After Acute Kidney Injury: Swedish Multi-centre Cohort Study

Acute Kidney Injury Clinical Trial

Official title:

Long Term Survival and Renal Outcomes in Critically Ill Patients After Acute Kidney Injury: Swedish Multi-centre Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424747
• Other study ID #: Karolinska Institutet SIR
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: April 23, 2015
• Start date: January 2005
• Est. completion date: December 2011

Study information

• Verified date: April 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study evaluates how outcome varies among critically ill patients with and without acute kidney injury. Data from the Swedish Intensive care register and other Swedish national registers is used to compare how survival and post discharge renal function differ between critically ill patients with and without acute kidney injury.

Description:

Background: Acute kidney injury is common amongst intensive care patients and is associated with extremely high mortality and morbidity in terms of increased risk of developing Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD). Patients with CKD are at increased risk of cardiovascular, cerebro-vascular disease and long term increased risk of death. Those patients who progress to ESRD have a 20% mortality risk per year in Sweden. Outcome after acute kidney injury in the Swedish critical care population has never previously been described.

Method: This cohort study uses Swedish national healthcare registers to investigate the epidemiology of acute kidney injury. The Swedish Intensive Care Register (SIR) provides the population base, with data extraction between 2005 and 2011. The information obtained is cross-matched by the Swedish board for health and welfare (Social Styrelsen) with other national registries. All data are returned anonymized and individual patients can not be identified in any way. Additionally analysis is performed on a group and not on an individual basis. The key to this data is held by Swedish board for health and welfare. The other national registries include the Swedish Cause of Death Register (Dödsregister), the Swedish renal register (Svensknjurregistret) and the in and out-patients registers (Öppen- slutenvårdsregister) these are used to obtain data on all cause mortality, co-morbidities, Pre and Post ICU CKD and ESRD. Epidemiological methods are used to analyse the data.

Investigators aim to describe outcome in terms of long-term mortality (up to five years) and renal morbidity (incidence of CKD and ESRD) in critically ill patients with and without de novo AKI in Sweden.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103000
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All first admissions of adult patients registered on the Swedish Intensive Care Register between January 1st 2005 and January 1st 2011.

Exclusion Criteria:

Patients under 18. Subjects with incomplete records. Patients previously diagnosed with Chronic Kidney Disease or End Stage Renal disease.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness

Intervention

Other:
• Acute Kidney Injury
We will identify and observe "exposure" to Acute Kidney Injury during Intensive Care admission.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Baxter Healthcare Corporation, Stockholm County Council, Sweden

References & Publications (7)

Adami HO, Hernán MA. Learning how to improve healthcare delivery: the Swedish Quality Registers. J Intern Med. 2015 Jan;277(1):87-9. doi: 10.1111/joim.12315. Epub 2014 Nov 24. — View Citation

Bellomo R, Kellum JA, Ronco C. Acute kidney injury. Lancet. 2012 Aug 25;380(9843):756-66. doi: 10.1016/S0140-6736(11)61454-2. Epub 2012 May 21. Review. — View Citation

Bellomo R. The epidemiology of acute renal failure: 1975 versus 2005. Curr Opin Crit Care. 2006 Dec;12(6):557-60. Review. — View Citation

Emilsson L, Lindahl B, Köster M, Lambe M, Ludvigsson JF. Review of 103 Swedish Healthcare Quality Registries. J Intern Med. 2015 Jan;277(1):94-136. doi: 10.1111/joim.12303. Epub 2014 Sep 27. Review. — View Citation

Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. Erratum in: N Engl J Med. 2008;18(4):4. — View Citation

Goldstein SL, Jaber BL, Faubel S, Chawla LS; Acute Kidney Injury Advisory Group of American Society of Nephrology. AKI transition of care: a potential opportunity to detect and prevent CKD. Clin J Am Soc Nephrol. 2013 Mar;8(3):476-83. doi: 10.2215/CJN.12101112. Review. — View Citation

Rimes-Stigare C, Awad A, Mårtensson J, Martling CR, Bell M. Long-term outcome after acute renal replacement therapy: a narrative review. Acta Anaesthesiol Scand. 2012 Feb;56(2):138-46. doi: 10.1111/j.1399-6576.2011.02567.x. Epub 2011 Oct 19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		5 year	No
Secondary	Incidence of Chronic Kidney Disease		5 years	No
Secondary	Incidence of End Stage Renal Failure		5 years	No