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

NCT04022655 | Unknown

• 1 other identifier: 4/8/19
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasculitis; Systemic Lupus Erythematosus; Myositis

Keywords

Intensive Care Unit; Mortality; Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  From date of admission to the ICU until the date of death from any cause assessed up to 52 weeks

Secondary Outcomes (4)

• Risk of renal replacement therapy

  From date of admission to the ICU until the date of event assessed up to 52 weeks

• Need for catecholamines

  From date of admission to the ICU until the date of event assessed up to 52 weeks

• Need for ventilation

  From date of admission to the ICU until the date of event assessed up to 52 weeks

• Need for cardiopulmonary resuscitation

  From date of admission to the ICU until the date of event assessed up to 52 weeks

Study Arms (1)

ANCA-associated Vasculitis

Patients with ANCA-associated vasculitis admitted to the ICU

Other: ICU Care

Interventions

ICU Care OTHER

No intervention

ANCA-associated Vasculitis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients with incomplete or missing data

Sponsors & Collaborators

• University of Göttingen: lead
• University Medical Center Goettingen: collaborator

Study Sites (1)

University Medical Center Göttingen

Göttingen, Germany

RECRUITING

MeSH Terms

Conditions

Vasculitis; Lupus Erythematosus, Systemic; Myositis; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Peter Korsten, MD

  University Medical Center Göttingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Korsten, MD

CONTACT

+49-551-398904; peter.korsten@med.uni-goettingen.de

Radovan Vasko, MD

CONTACT

radovan.vasko@med.uni-goettingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Head of the Rheumatology Clinical Trials Unit, Prinicipal Investigator

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 17, 2019
• Study Start: July 22, 2019
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)