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Clinical Characteristics and Outcomes of SLE Patients Admitted to Critical Care Unit

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ClinicalTrials.gov Identifier: NCT05418855
Recruitment Status : Not yet recruiting
First Posted : June 14, 2022
Last Update Posted : June 14, 2022
Information provided by (Responsible Party):
MOHussein, Assiut University

Brief 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.

Condition or disease
Systemic Lupus Erythematosus

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Characteristics and Outcomes of SLE Patients Admitted to Assiut University Hospital Critical Care Unit
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients fulfill the Systemic lupus international Collaborating Clinics (SLICC) Criteria for classification of SLE .

Inclusion Criteria:

  • SLE Patients Admitted to ICU.

Exclusion Criteria:

  • Patients who stayed <48 h in ICU.
  • Patients with major chronic organ disease not related to SLE or terminal cancer.

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): NCT05418855

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Contact: Mohamed Fawzy Hussein, Resident 01153375657 mo.fa@yahoo.com
Contact: Salwa Salah Elgendi, Professor 01005766155 salwaelgendi@yahoo.com

Sponsors and Collaborators
Assiut University
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Principal Investigator: Ahmed Bahy Ahmed, lecturer Assiut University
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Responsible Party: MOHussein, Resident doctor at critical care unit of internal medicine department at Assiut University Hospitals, Assiut University
ClinicalTrials.gov Identifier: NCT05418855    
Other Study ID Numbers: SLE Patients in CCU.
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases