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

NCT ID: NCT06404723

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-04-01

Brief Summary

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.

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).

Conditions

Systemic Lupus Erythematosus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Control Group

: this group contains 50 healthy individual

Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio

Intervention Type: DIAGNOSTIC_TEST

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.

Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio

Intervention Type: DIAGNOSTIC_TEST

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.

Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio

Intervention Type: DIAGNOSTIC_TEST

to detect their relation to disease activity to use as predective and prognostic tools

Interventions

Fibrinogen to albumin Ratio and C-reactive to Albumin Ratio

to detect their relation to disease activity to use as predective and prognostic tools

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Manar Gamal Mohamed

Specialist of Physical Medicine, Rheumatology and Rehabilitation at Medical Admintsration at Sohag University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Manar G Mohammed, spcialist

Role: CONTACT

manar_gamal_post@med.sohag.edu.eg

+2 01069191994

Esam M Abu Al-Fadl, professor

Role: CONTACT

essam_mohamed@med.sohag.edu.eg

+2 01125677779

Other Identifiers

soh-Med-24-02-07MD

Identifier Type: -

Identifier Source: org_study_id