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

NCT ID: NCT02424747

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2011-12-31

Brief 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.

Detailed 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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

De Novo Acute Kidney Injury

Patients who developed Acute Kidney Injury during intensive care admission and not previously diagnosed with chronic kidney disease or end stage renal disease.

Acute Kidney Injury

Intervention Type: OTHER

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

No Acute Kidney Injury.

Intensive care patients not diagnosed with acute kidney Injury during admission and not previously diagnosed with Chronic Kidney Disease or End Stage Renal Disease.

No interventions assigned to this group

Interventions

Acute Kidney Injury

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

Intervention Type: OTHER

Eligibility Criteria

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.

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Claire Rimes-Stigare

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claire Stigare, MD

Role: PRINCIPAL_INVESTIGATOR

karolinska University Hospital, Karolinska Institute

References

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.

Reference Type: BACKGROUND

PMID: 23471414 (View on PubMed)

Bellomo R. The epidemiology of acute renal failure: 1975 versus 2005. Curr Opin Crit Care. 2006 Dec;12(6):557-60. doi: 10.1097/01.ccx.0000247443.86628.68.

Reference Type: BACKGROUND

PMID: 17077686 (View on PubMed)

Rimes-Stigare C, Awad A, Martensson 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.

Reference Type: BACKGROUND

PMID: 22092145 (View on PubMed)

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. doi: 10.1056/NEJMoa041031.

Reference Type: BACKGROUND

PMID: 15385656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22617274 (View on PubMed)

Emilsson L, Lindahl B, Koster 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.

Reference Type: BACKGROUND

PMID: 25174800 (View on PubMed)

Adami HO, Hernan 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. No abstract available.

Reference Type: BACKGROUND

PMID: 25270255 (View on PubMed)

Rimes-Stigare C, Frumento P, Bottai M, Martensson J, Martling CR, Bell M. Long-term mortality and risk factors for development of end-stage renal disease in critically ill patients with and without chronic kidney disease. Crit Care. 2015 Nov 3;19:383. doi: 10.1186/s13054-015-1101-8.

Reference Type: DERIVED

PMID: 26526622 (View on PubMed)

Other Identifiers

Karolinska Institutet SIR

Identifier Type: -

Identifier Source: org_study_id