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

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ClinicalTrials.gov Identifier: NCT04022655
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
University Medical Center Goettingen
Information provided by (Responsible Party):
Peter Korsten, University of Göttingen

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
Vasculitis Systemic Lupus Erythematosus Myositis Other: ICU Care

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Study Type : Observational
Estimated 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 : July 22, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019


Group/Cohort Intervention/treatment
ANCA-associated Vasculitis
Patients with ANCA-associated vasculitis admitted to the ICU
Other: ICU Care
No intervention




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Risk of renal replacement therapy [ Time Frame: From date of admission to the ICU until the date of event assessed up to 52 weeks ]
  2. Need for catecholamines [ Time Frame: From date of admission to the ICU until the date of event assessed up to 52 weeks ]
  3. Need for ventilation [ Time Frame: From date of admission to the ICU until the date of event assessed up to 52 weeks ]
  4. Need for cardiopulmonary resuscitation [ Time Frame: From date of admission to the ICU until the date of event assessed up to 52 weeks ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with systemic autoimmune diseases admitted to the ICU at the University Medical Center Göttingen
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with incomplete or missing data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022655


Contacts
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Contact: Peter Korsten, MD +49-551-398904 peter.korsten@med.uni-goettingen.de
Contact: Radovan Vasko, MD radovan.vasko@med.uni-goettingen.de

Locations
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Germany
University Medical Center Göttingen Recruiting
Göttingen, Germany
Contact: Peter Korsten, MD    0049-551-39 ext 8904    peter.korsten@med.uni-goettingen.de   
Contact: Radovan Vasko, MD       radovan.vasko@med.uni-goettingen.de   
Sponsors and Collaborators
University of Göttingen
University Medical Center Goettingen
Investigators
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Principal Investigator: Peter Korsten, MD University Medical Center Göttingen

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Responsible Party: Peter Korsten, Attending Physician, Head of the Rheumatology Clinical Trials Unit, Prinicipal Investigator, University of Göttingen
ClinicalTrials.gov Identifier: NCT04022655     History of Changes
Other Study ID Numbers: 4/8/19
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Korsten, University of Göttingen:
Intensive Care Unit
Mortality
Autoimmune Diseases
Additional relevant MeSH terms:
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Myositis
Vasculitis
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases