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

April 23, 2015 updated by: Claire Rimes-Stigare, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

103000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 5 year
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Chronic Kidney Disease
Time Frame: 5 years
5 years
Incidence of End Stage Renal Failure
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Baxter Healthcare Corporation
Region Stockholm

Investigators

  • Principal Investigator: Claire Stigare, MD, karolinska University Hospital, Karolinska Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Karolinska Institutet SIR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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