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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04022655
• Other study ID #: 4/8/19
• Status: Recruiting
• Start date: July 22, 2019
• Est. completion date: October 2019

Study information

• Verified date: July 2019
• Source: University of Göttingen
• Contact: Peter Korsten, MD
• Phone: +49-551-398904
• Email: peter.korsten[@]med.uni-goettingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with incomplete or missing data

Related Conditions & MeSH terms

• Autoimmune Diseases
• Lupus Erythematosus, Systemic
• Myositis
• Systemic Lupus Erythematosus
• Vasculitis

Intervention

Other:
• ICU Care
No intervention

Locations

Country	Name	City	State
Germany	University Medical Center Göttingen	Göttingen

Sponsors (2)

Lead Sponsor	Collaborator
University of Göttingen	University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality		From date of admission to the ICU until the date of death from any cause assessed up to 52 weeks
Secondary	Risk of renal replacement therapy		From date of admission to the ICU until the date of event assessed up to 52 weeks
Secondary	Need for catecholamines		From date of admission to the ICU until the date of event assessed up to 52 weeks
Secondary	Need for ventilation		From date of admission to the ICU until the date of event assessed up to 52 weeks
Secondary	Need for cardiopulmonary resuscitation		From date of admission to the ICU until the date of event assessed up to 52 weeks