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

• Sponsor: University of Göttingen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04022655
• Collaborator: University Medical Center Goettingen (Other)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 2.3
• Patients Per Site Per Month: 25.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vasculitis; Systemic Lupus Erythematosus; Myositis	Other: ICU Care

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit - Retrospective Analysis at a Single Tertiary Care Center
• Actual Study Start Date: Jul 22, 2019
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
ANCA-associated Vasculitis Patients with ANCA-associated vasculitis admitted to the ICU	Other: ICU Care; No intervention

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Risk of renal replacement therapy [From date of admission to the ICU until the date of event assessed up to 52 weeks]

2. Need for catecholamines [From date of admission to the ICU until the date of event assessed up to 52 weeks]

3. Need for ventilation [From date of admission to the ICU until the date of event assessed up to 52 weeks]

4. Need for cardiopulmonary resuscitation [From date of admission to the ICU until the date of event assessed up to 52 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with incomplete or missing data

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Göttingen	Göttingen		Germany

Sponsors and Collaborators

• University of Göttingen
• University Medical Center Goettingen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Korsten, Attending Physician, Head of the Rheumatology Clinical Trials Unit, Prinicipal Investigator, University of Göttingen
• ClinicalTrials.gov Identifier: NCT04022655
• Other Study ID Numbers: 4/8/19
• First Posted: Jul 17, 2019
• Last Update Posted: Jul 24, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter Korsten, Attending Physician, Head of the Rheumatology Clinical Trials Unit, Prinicipal Investigator, University of Göttingen: Intensive Care Unit; Mortality; Autoimmune Diseases
• Additional relevant MeSH terms: Myositis; Vasculitis; Lupus Erythematosus, Systemic; Autoimmune Diseases

Study Results

No Results Posted as of Jul 24, 2019