Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit

July 22, 2019 updated by: Peter Korsten, University of Göttingen

Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit - Retrospective Analysis at a Single Tertiary Care Center

Autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, myositis, or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, may affect multiple organ systems. Occasionally, patients deteriorate acutely requiring advanced care in an intensive care unit (ICU). In an ICU setting, mortality is estimated with scoring systems, such as APACHE or SAPSII. Since there are limited data available on their use in autoimmune diseases, with the current study, we aim to assess the usefulness of these ICU scores and analyze predictors of mortality in this particular group of patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with systemic autoimmune diseases admitted to the ICU at the University Medical Center Göttingen

Description

Inclusion Criteria:

  • Patients admitted to the ICU at the University Medical Center Göttingen

Exclusion Criteria:

  • Patients with incomplete or missing data

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
ANCA-associated Vasculitis
Patients with ANCA-associated vasculitis admitted to the ICU
Other: ICU Care
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-hospital mortality
Time Frame: From date of admission to the ICU until the date of death from any cause assessed up to 52 weeks
From date of admission to the ICU until the date of death from any cause assessed up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Risk of renal replacement therapy
Time Frame: From date of admission to the ICU until the date of event assessed up to 52 weeks
From date of admission to the ICU until the date of event assessed up to 52 weeks
Need for catecholamines
Time Frame: From date of admission to the ICU until the date of event assessed up to 52 weeks
From date of admission to the ICU until the date of event assessed up to 52 weeks
Need for ventilation
Time Frame: From date of admission to the ICU until the date of event assessed up to 52 weeks
From date of admission to the ICU until the date of event assessed up to 52 weeks
Need for cardiopulmonary resuscitation
Time Frame: From date of admission to the ICU until the date of event assessed up to 52 weeks
From date of admission to the ICU until the date of event assessed up to 52 weeks

Collaborators and Investigators

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

Sponsor

University of Göttingen

Collaborators

University Medical Center Goettingen

Investigators

  • Principal Investigator: Peter Korsten, MD, University Medical Center Göttingen

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 (ACTUAL)

July 22, 2019

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

July 12, 2019

First Submitted That Met QC Criteria

July 13, 2019

First Posted (ACTUAL)

July 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4/8/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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