VasculitisNCT04022655
Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit
An observational study of Vasculitis and Systemic Lupus Erythematosus, run by University of Göttingen at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Vasculitis, Systemic Lupus Erythematosus, Myositis
- What is being tested?
- ICU Care
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jul 2019to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with systemic autoimmune diseases admitted to the ICU at the University Medical Center Göttingen
Who may be able to join
- Patients admitted to the ICU at the University Medical Center Göttingen
Who cannot join
- Patients with incomplete or missing data
Trial locations and contacts
1 site in 1 country.
Radovan Vasko, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Göttingen
Göttingen
Peter Korsten, MD, 0049-551-39 ext. 8904, peter.korsten@med.uni-goettingen.de
Radovan Vasko, MD, radovan.vasko@med.uni-goettingen.de
About this study
Official title: Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit - Retrospective Analysis at a Single Tertiary Care Center
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
- Being tested
- ICU Care
- Keywords
- Intensive Care Unit, Mortality, Autoimmune Diseases
- Medical subject headings
- Vasculitis, Lupus Erythematosus, Systemic, Myositis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU CareOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| ANCA-associated Vasculitis | Patients with ANCA-associated vasculitis admitted to the ICU Receives: Other: ICU Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: 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
Measured: From date of admission to the ICU until the date of event assessed up to 52 weeks
Need for catecholamines
Measured: From date of admission to the ICU until the date of event assessed up to 52 weeks
Need for ventilation
Measured: From date of admission to the ICU until the date of event assessed up to 52 weeks
Need for cardiopulmonary resuscitation
Measured: From date of admission to the ICU until the date of event assessed up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start22 Jul 2019
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasculitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Goettingen
- Responsible party
- Principal investigator, Peter Korsten, University of Göttingen
- Investigators
- Peter Korsten, MD, Principal investigator, University Medical Center Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022655
- Sponsor's protocol ID
- 4/8/19
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit - Retrospective Analysis at a Single Tertiary Care Center
- ClinicalTrials.gov ID
- NCT04022655
- Acronym / sponsor ID
- 4/8/19
- Conditions
- Vasculitis, Systemic Lupus Erythematosus, Myositis
- Keywords
- Intensive Care Unit, Mortality, Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- University Medical Center Goettingen
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANCA-associated Vasculitis | – | Other: ICU CarePatients with ANCA-associated vasculitis admitted to the ICU |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with systemic autoimmune diseases admitted to the ICU at the University Medical Center Göttingen
Key inclusion criteria (1 listed)
- Patients admitted to the ICU at the University Medical Center Göttingen
Key exclusion criteria (1 listed)
- Patients with incomplete or missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU CareNo intervention | Other | ANCA-associated Vasculitis |
Primary outcome
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
4 secondary outcomes
Risk of renal replacement therapy
Time frame: From date of admission to the ICU until the date of event assessed up to 52 weeks
Need for catecholamines
Time frame: From date of admission to the ICU until the date of event assessed up to 52 weeks
Need for ventilation
Time frame: From date of admission to the ICU until the date of event assessed up to 52 weeks
Need for cardiopulmonary resuscitation
Time frame: From date of admission to the ICU until the date of event assessed up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radovan Vasko, MD contact
Peter Korsten, MD principal investigator
University Medical Center Göttingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasculitis and Systemic Lupus Erythematosus, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Korsten, MD (+49-551-398904, peter.korsten@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.