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NCT Number: 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

To identify clinical and laboratory predictors of ICU admission and in-hospital mortality among hospitalized adults with lupus nephritis by evaluating the prognostic performance of NLR and CAR, comparing them with CRP and albumin using ROC analysis, determining optimal cutoff values, and identifying independent predictors through multivariable logistic regression

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants of ICU admission or In-hospital mortality.

    Time frame: 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Omar Ahmed

CONTACT

[email protected]

+201023658355

Khaled Samir Malak

CONTACT

[email protected]

+201554715247

Sponsors and collaborators

Lead sponsor

Khaled Samir Malak Nashed

Other

Collaborators

  • Assiut University

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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