The Predictive and Prognostic Values of the Fibrinogen to Albumin Ratio and C-reactive Protien to Albumin Ratio in Systemic Lupus Erythematosus Patients

The aim of the study was to study the predictive value of FAR and CAR in order to provide a new predictive biomarkers for the disease activity and prognosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Diagnostic test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio

Detailed Description

A total of 150 participants were included in a Case-Control study:

1. Healthy control group: this group contains 50 healthy individual.
2. Lupus simplex (mild and moderate disease activity) group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score less than 15.
3. Severe disease activity group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score ≥ 15.

Setting:

This study will be conducted to All patients will enter to The Rheumatology Department, Sohag University Hospital for one year.

Inclusion criteria:

Patients diagnosed as SLE according to SLICC 2012 or ACE/EULAR 2017 classification criteria with

1. ≥18 years of age.
2. Complete clinical and laboratory investigations.
3. No concomitant infection, systemic or other autoimmune diseases.

Exclusion criteria:

Patients were excluded from the study if they had any of the following:

1. <18 years of age,
2. Incomplete clinical data and laboratory indicators.
3. End-stage kidney disease (defned as requiring dialysis, kidney transplantation, or estimated glomerular fltration rate (eGFR)<15 mL/min/1.73 m2

4. Patients with:

   1. Acute infectious diseases, HIV infection carriers,
   2. Concomitant systemic diseases such as chronic obstructive lung disease, coronary artery disease, cancer, thyroid function disorder, hematological disorders, acute or chronic liver and renal diseases.
   3. Patients with had other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis, or primary Sjogren's syndrome.

Methods:

All patients will be subjected to the following:

1. Thorough medical history from the patients

2. Full clinical examination including:

   1. General examination and vital signs.
   2. Complete rheumatological examination.
   3. Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score.
3. Laboratory examinations include:

1. Complete blood picture (CBC). 2. Erythrocyte sedimentation rate (ESR). 3. C-reactive protein (CRP) 4. Liver function tests (LFT). 5. Renal investigations:

1. Kidney functions
2. Urine analysis
3. 24 hours protein in urine and/or A/C ratio or p/c ratio.
4. eGFR
5. Renal biopsy. 6. ANA by IF. 4. Specific tests: a. Fibrinogen to Albumin ratio (FAR). b. C-Reactive protein to Albumin Ratio (CAR).

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Manar G Mohammed, spcialist; Phone Number: +2 01069191994; Email: manar_gamal_post@med.sohag.edu.eg
• Study Contact Backup: Name: Esam M Abu Al-Fadl, professor; Phone Number: +2 01125677779; Email: essam_mohamed@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

A total of 150 participants were included in a Case-Control study:

1. Healthy control group: this group contains 50 healthy individual.
2. Lupus simplex (mild and moderate disease activity) group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score less than 15.
3. Severe disease activity group: this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score ≥ 15.

Description

Inclusion Criteria:

Patients diagnosed as SLE according to SLICC 2012 or ACE/EULAR 2017 classification criteria with

1. ≥18 years of age.
2. Complete clinical and laboratory investigations.
3. No concomitant infection, systemic or other autoimmune diseases.

Exclusion Criteria:

Patients were excluded from the study if they had any of the following:

1. <18 years of age,
2. Incomplete clinical data and laboratory indicators.
3. End-stage kidney disease (defned as requiring dialysis, kidney transplantation, or estimated glomerular fltration rate (eGFR)<15 mL/min/1.73 m2

4. Patients with:

   1. Acute infectious diseases, HIV infection carriers,
   2. Concomitant systemic diseases such as chronic obstructive lung disease, coronary artery disease, cancer, thyroid function disorder, hematological disorders, acute or chronic liver and renal diseases.
   3. Patients with had other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis, or primary Sjogren's syndrome.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control Group; : this group contains 50 healthy individual	Diagnostic test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio; to detect their relation to disease activity to use as predective and prognostic tools
Lupus Simplex (mild to moderate disease) activity Group; this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score less than 15.	Diagnostic test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio; to detect their relation to disease activity to use as predective and prognostic tools
Severe disease activity Group; this group contains 50 patients with a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score ≥ 15.	Diagnostic test: Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio; to detect their relation to disease activity to use as predective and prognostic tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibrinogen/Albumin ratio, C-reactive protein /Albumin ratio	detect if the results approve their use as a predictive and prognostic tools for SLE	1-6-2024 to 1-6-2025

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: soh-Med-24-02-07MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No