Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404723
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-05
Brief Title:
The Predictive and Prognostic Values of the Fibrinogen to Albumin Ratio and C-reactive Protien to Albumin Ratio in Systemic Lupus Erythematosus Patients
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
The Predictive and Prognostic Values of the Fibrinogen to Albumin Ratio and C-reactive Protien to Albumin Ratio in Systemic Lupus Erythematosus Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ACEEULAR 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 eGFR15 mLmin173 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 Sjogrens 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 andor AC ratio or pc 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
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 ACEEULAR 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 eGFR15 mLmin173 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 Sjogrens 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 andor AC ratio or pc 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None