NCT02424747

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

6.9 years

First QC Date

April 20, 2015

Last Update Submit

April 23, 2015

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Mortality

    5 year

Secondary Outcomes (2)

  • Incidence of Chronic Kidney Disease

    5 years

  • Incidence of End Stage Renal Failure

    5 years

Study Arms (2)

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.

Other: Acute Kidney Injury

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.

Interventions

Acute Kidney InjuryOTHER

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

De Novo Acute Kidney Injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population was provided by the Swedish Intensive Care register and included patients receiving intensive care treatment between January 2005 and January 2011

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 23471414BACKGROUND

  • 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.

    PMID: 17077686BACKGROUND

  • 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.

    PMID: 22092145BACKGROUND

  • 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.

    PMID: 15385656BACKGROUND

  • 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.

    PMID: 22617274BACKGROUND

  • 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.

    PMID: 25174800BACKGROUND

  • 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.

    PMID: 25270255BACKGROUND

  • 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.

    PMID: 26526622DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Claire Stigare, MD

    karolinska University Hospital, Karolinska Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 23, 2015

Study Start

January 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 24, 2015

Record last verified: 2015-04