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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mohamed Fawzy Hussein, Resident contact

01153375657

mo.fa@yahoo.com

Salwa Salah Elgendi, Professor contact

01005766155

salwaelgendi@yahoo.com

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.

Medical subject headings
Lupus Erythematosus, Systemic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted14 Jun 2022
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Feb 2023 (estimated)

Resources

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)
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

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.

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