Systemic Lupus ErythematosusNCT05418855
Clinical Characteristics and Outcomes of SLE Patients Admitted to Critical Care Unit
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
Trial summary
The aim of the present work is to determine the frequency of critical complications of SLE patients admitted to the intensive care unit,study the risk factors and out comes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Feb 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients fulfill the Systemic lupus international Collaborating Clinics (SLICC) Criteria for classification of SLE .
Who may be able to join
- SLE Patients Admitted to ICU.
Who cannot join
- Patients who stayed <48 h in ICU.
- Patients with major chronic organ disease not related to SLE or terminal cancer.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Characteristics and Outcomes of SLE Patients Admitted to Assiut University Hospital Critical Care Unit
The aim of the present work is to determine the frequency of critical complications of SLE patients admitted to the intensive care unit,study the risk factors and out comes.
Read the detailed description
Systemic lupus erythematosus (SLE) is a systemic heterogeneous autoimmune disease with a highly variable course and prognosis that many different organs may be affected . It has wide spectrum of clinical presentation that affects all ages and ethnicities . Child-bearing women most often afflicted by this diseases, but with different disease manifestations and with variable severity .
The pathogenesis of SLE is complex and still largely unknown. Genetic, environmental, and hormonal factors contribute to disease susceptibility . The diagnosis of SLE is based on characteristic clinical findings of the skin, joints, kidneys, and the central nervous system, as well as on serological parameters such as antinuclear antibodies (ANA) . SLE mainly causes damage to the kidney, heart, joints, blood vessels, liver, lungs and the nervous system . Since SLE is a heterogeneous disease, its complications may vary and the severity or intensity depends on the area affected. Pulmonary hypertension, alveolar haemorrhage, thrombocytopenia, catastrophic antiphospholipid syndrome (APS), haemolytic anemia, neutropenia, blood cancer and thrombotic thrombocytopenic purpura, atherosclerosis, pericardial tamponade myocarditis, heart failure, arthritis, vasculitis, adrenal insufficiency, lupus nephritis (LN), neuropsychiatric disorders, pancreatitis, and myelitis are some of the major complications of SLE . In a previous study on Egyptian SLE patients, pleuro-pulmonary system was found to be one of the most commonly affected systems; pleurisy being the most frequent clinical finding followed by pulmonary infection and disease activity was an important predictor for infection .
Lupus flares and infections are the most common causes of admission to the ICU in patients with SLE. Pertaining to complications from infections, lower pulmonary tract infections are typically more severe and frequent.
A number of studies have addressed the characteristics and outcomes of critically ill SLE patients. In a cohort of 2870 SLE patients retrieved from a national database, the leading causes of ICU admission were found to be infections and organ dysfunction (neurological, cardiovascular, and respiratory systems).
Ethnic differences, availability of therapy, and health-care referral systems may impact SLE manifestation and prognosis. Few studies have provided a clinical characterization of SLE patients admitted to the ICU, and data on predictors of patient outcomes are discordant.
- Conditions
- Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
complications of SLE patients admitted to the intensive care unit.
Number of incidence of complications depending on these measures will be reported Liver bilrubin alb Urea creatinine GFR CBC Ecg X Ray chest cardiomegaly effusion pulmonary edema Ct brain hge infarction Blood gases Clinical data Fever Blood pressure
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHussein, Assiut University
- Investigators
- Ahmed Bahy Ahmed, lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418855
- Sponsor's protocol ID
- SLE Patients in CCU.
- Status last verified
- Jun 2022
- First submitted
- 4 Feb 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcomes of SLE Patients Admitted to Assiut University Hospital Critical Care Unit
- ClinicalTrials.gov ID
- NCT05418855
- Acronym / sponsor ID
- SLE Patients in CCU.
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 14 Jun 2022 (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.
The aim of the present work is to determine the frequency of critical complications of SLE patients admitted to the intensive care unit,study the risk factors and out comes.
Detailed description
Systemic lupus erythematosus (SLE) is a systemic heterogeneous autoimmune disease with a highly variable course and prognosis that many different organs may be affected . It has wide spectrum of clinical presentation that affects all ages and ethnicities . Child-bearing women most often afflicted by this diseases, but with different disease manifestations and with variable severity .
The pathogenesis of SLE is complex and still largely unknown. Genetic, environmental, and hormonal factors contribute to disease susceptibility . The diagnosis of SLE is based on characteristic clinical findings of the skin, joints, kidneys, and the central nervous system, as well as on serological parameters such as antinuclear antibodies (ANA) . SLE mainly causes damage to the kidney, heart, joints, blood vessels, liver, lungs and the nervous system . Since SLE is a heterogeneous disease, its complications may vary and the severity or intensity depends on the area affected. Pulmonary hypertension, alveolar haemorrhage, thrombocytopenia, catastrophic antiphospholipid syndrome (APS), haemolytic anemia, neutropenia, blood cancer and thrombotic thrombocytopenic purpura, atherosclerosis, pericardial tamponade myocarditis, heart failure, arthritis, vasculitis, adrenal insufficiency, lupus nephritis (LN), neuropsychiatric disorders, pancreatitis, and myelitis are some of the major complications of SLE . In a previous study on Egyptian SLE patients, pleuro-pulmonary system was found to be one of the most commonly affected systems; pleurisy being the most frequent clinical finding followed by pulmonary infection and disease activity was an important predictor for infection .
Lupus flares and infections are the most common causes of admission to the ICU in patients with SLE. Pertaining to complications from infections, lower pulmonary tract infections are typically more severe and frequent.
A number of studies have addressed the characteristics and outcomes of critically ill SLE patients. In a cohort of 2870 SLE patients retrieved from a national database, the leading causes of ICU admission were found to be infections and organ dysfunction (neurological, cardiovascular, and respiratory systems).
Ethnic differences, availability of therapy, and health-care referral systems may impact SLE manifestation and prognosis. Few studies have provided a clinical characterization of SLE patients admitted to the ICU, and data on predictors of patient outcomes are discordant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients fulfill the Systemic lupus international Collaborating Clinics (SLICC) Criteria for classification of SLE .
Key inclusion criteria (1 listed)
- SLE Patients Admitted to ICU.
Key exclusion criteria (2 listed)
- Patients who stayed <48 h in ICU.
- Patients with major chronic organ disease not related to SLE or terminal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
complications of SLE patients admitted to the intensive care unit.
Time frame: Baseline
Number of incidence of complications depending on these measures will be reported Liver bilrubin alb Urea creatinine GFR CBC Ecg X Ray chest cardiomegaly effusion pulmonary edema Ct brain hge infarction Blood gases Clinical data Fever Blood pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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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.
Ahmed Bahy Ahmed, lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
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 2 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 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed Fawzy Hussein, Resident (01153375657, mo.fa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications of SLE patients admitted to the intensive care unit. (time frame: Baseline). 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 14 Jun 2022.