Systemic Immune Inflammatory Index in Systemic Lupus Erythematosus

Association of Systemic Immune Inflammatory Index with Disease Activity and Lupus Nephritis in Patients with Systemic Lupus Erythematosus

This study aims to investigate the association between the systemic immune-inflammation index and disease activity, as well as lupus nephritis in patients with systemic lupus erythematosus

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus; Lupus Nephritis
• Intervention / Treatment: Diagnostic test: systemic immune inflammatory index

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Shorouk Mohamed abdelmageed, master degree; Phone Number: 02 +01099082079; Email: Shrouk011107@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 1670005
    • Recruiting
    • Sohag Faculty
    • Contact: Shorouk Mohamed abdelmageed, master degree; Phone Number: 02+01099082079; Email: Shrouk011107@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

patients attending in rheumatology outpatient clinic, sohag university hospital

Description

Inclusion Criteria:

• o Older than 16 years

  • In a patient with SLE, patients who fulfill the criteria of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).
  • In patients with LN, patients whose diagnosis is confirmed by kidney biopsy and pathohistological verification (WHO classification, and the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification.

Exclusion Criteria:

• Patients with other autoimmune rheumatological diseases, lymphoproliferative disorders, malignancies, liver diseases, end-stage kidney disease, diabetic nephropathy, active infections, recent history of blood transfusion and patients with deficiencies in vitamin B12, folate, and iron are excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients diagnosed with systemic lupus and lupus nephritis; this group will include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculatedusing the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.	Diagnostic test: systemic immune inflammatory index; Systemic immune inflammatory index (SII) is a combination of three hematological parameters (platelets, neutrophils, and lymphocytes) and it is calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.
patients diagnosed with systemic lupus without lupus nephritis; this group will also include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.	Diagnostic test: systemic immune inflammatory index; Systemic immune inflammatory index (SII) is a combination of three hematological parameters (platelets, neutrophils, and lymphocytes) and it is calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.
healthy control group; this group will also include 30 healthy controls , they will undergo the following: The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.	Diagnostic test: systemic immune inflammatory index; Systemic immune inflammatory index (SII) is a combination of three hematological parameters (platelets, neutrophils, and lymphocytes) and it is calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
association of systemic immune-inflammation index (SII) disease activity in systemic lupus erythematosus	This study aims to investigate if there is an association between the systemic immune-inflammation index (SII) and disease activity in patients with systemic lupus erythematosus using SLEDAI(systemic lupus erythematosus disease activity index) as a valid index to compare results with	baseline
association of systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus	This study aims to investigate the association between the systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus	baseline

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• 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; Lupus Nephritis
• Other Study ID Numbers: soh-Med-25-1-2MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No