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

August 24, 2026 updated by: Khaled Samir Malak Nashed
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

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Hospitalized adult patients with Lupus Nephritis.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Samir Kamal, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

August 21, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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