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NCT Number: NCT02424747

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Acute Kidney Injury

Other

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

Primary outcomes

  1. Mortality

    Time frame: 5 year

Secondary outcomes

  1. Incidence of Chronic Kidney Disease

    Time frame: 5 years

  2. Incidence of End Stage Renal Failure

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Baxter Healthcare Corporation
  • Region Stockholm

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Apr 23, 2015
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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