- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07783711
Predictors of ICU Admission and In-Hospital Mortality in Hospitalized Patients With Lupus Nephritis: The Prognostic Value of Neutrophil-to-Lymphocyte Ratio and C Reactive Protein to Serum Albumin Ratio
Study Overview
Status
Conditions
Detailed Description
Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune disease characterized by immune dysregulation, autoantibody production, immune complex deposition, and complement activation, leading to inflammation and irreversible organ damage. Despite advances in immunosuppressive therapy, SLE remains associated with significant morbidity, frequent hospitalizations, and premature mortality. Lupus nephritis (LN), affecting approximately 40-60% of patients with SLE, is one of its most severe manifestations and a major cause of chronic kidney disease, endstage kidney disease, cardiovascular complications, recurrent hospitalizations, and death. Hospitalized patients with LN often develop severe disease flares, acute kidney injury, nephrotic syndrome, infections, pulmonary hemorrhage, neuropsychiatric lupus, thrombotic microangiopathy, or cardiovascular complications requiring intensive care, where mortality remains high Early identification of patients at risk of clinical deterioration is essential to improve monitoring and optimize treatment. Several demographic, clinical, and laboratory factors have been linked to poor outcomes, including older age, active disease, infection, impaired kidney function, thrombocytopenia, hypocomplementemia, and hypoalbuminemia. However, most available studies are retrospective or limited to selected SLE populations.
Recently, inexpensive inflammatory biomarkers derived from routine laboratory tests have gained attention. The neutrophil-to-lymphocyte ratio (NLR) reflects systemic inflammatory activity and has been associated with disease activity, acute kidney injury, ICU admission, and mortality. The C-reactive protein-to-albumin ratio (CAR), combining inflammatory and nutritional status, has also demonstrated prognostic value in inflammatory and critically ill patients.
This prospective observational cohort study aims to identify the clinical and laboratory predictors of ICU admission and in-hospital mortality among hospitalized patients with lupus nephritis, with particular emphasis on evaluating the prognostic performance of NLR and CAR as simple, readily available biomarkers for early risk stratification.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Khaled Samir Malak
- Phone Number: +201554715247
- Email: Khaled.18313263@med.aun.edu.eg
Study Contact Backup
- Name: Alaa Omar Ahmed
- Phone Number: +201023658355
- Email: Alaa_omar11@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Age ≥18 years.
- Diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR Classification Criteria.
- Biopsy-proven lupus nephritis or clinically diagnosed lupus nephritis according to the treating nephrologist based on clinical, laboratory and immunological findings.
- Hospitalization because of active lupus nephritis or complications related to lupus nephritis.
- Provision of written informed consent.
Exclusion Criteria:
Age below 18 years.
- Previous kidney transplantation.
- Maintenance dialysis for more than three months before hospital admission.
- Active malignancy.
- Pregnancy.
- Refusal to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants of ICU admission or In-hospital mortality.
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Samir Kamal, Assiut University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Skin and Connective Tissue Diseases
- Lupus Nephritis
Other Study ID Numbers
- Prognosis in lupus nephritis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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