Predictors of Mortality in Patients With Autoimmune Disea... | NCT04022655

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

NCT04022655

Sponsor

University of Göttingen

Status

Unknown status

Last Update Posted

Jul 24, 2019Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Vasculitis
Systemic Lupus Erythematosus
Myositis

Interventions

ICU Care

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2019Actual

Primary Completion Date

Aug 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Jul 12, 2019

First Submission Date that Met QC Criteria

Jul 13, 2019

First Posted Date

Jul 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2019

Last Update Posted Date

Jul 24, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Korsten, Attending Physician, Head of the Rheumatology Clinical Trials Unit, Prinicipal Investigator, University of GöttingenPrincipal Investigator

Lead Sponsor

University of GöttingenOTHER

Collaborators

Name	Class
University Medical Center Goettingen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ANCA-associated Vasculitis		Patients with ANCA-associated vasculitis admitted to the ICU	Other: ICU Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICU Care	Other	No intervention	ANCA-associated Vasculitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the ICU at the University Medical Center Göttingen

Exclusion Criteria:

Patients with incomplete or missing data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Korsten, MD	Contact	+49-551-398904		peter.korsten@med.uni-goettingen.de
Radovan Vasko, MD	Contact			radovan.vasko@med.uni-goettingen.de

Overall Officials

Name	Affiliation	Role
Peter Korsten, MD	University Medical Center Göttingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Göttingen	Recruiting	Göttingen			Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014657	Vasculitis
D008180	Lupus Erythematosus, Systemic
D009220	Myositis
D001327	Autoimmune Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided