Renal Resistive Index as a Marker of Severity and Treatment Outcomes in Lupus Nephritis

Summary

All patients with SLE that will be admitted in internal medicine department from August 2019 to January 2021 are eligible to be targeted and included in the study. The diagnosis of SLE will be according to the 1997 American college of Romatology revised criteria (Hochberg 1997). SLE patients with lupus nephritis will take kidney biopsy for standard care of management according to American college of Romatology guidelines 2012. The study will include three groups as follow:

1 - SLE patients with lupus nephritis. 2- SLE patients without lupus nephritis 3-A group of age and sex matched healthy individuals. The first group will represent the study group while the second and third groups group will be taken as control group Exclusion criteria: patients with

1- Chronic renal failure 2- Diabetes mellitus (DM) 3-Obstructive nephropathy 4- Renal artery stenosis 5- Hypertension 6- Heart failure 7- Hepatic diseases. 8- Existing intra renal A-V fistula. 9-Renal vein thrombosis

Aims of the Research :

1. Assessment of the renal resistive index in patients with lupus nephritis (LN), in SLE patients without lupus nephritis and in the healthy controls.
2. Comparing the renal resistive index values in SLE patients with lupus nephritis with the SLE patients without LN and healthy controls.
3. Assessment of the correlation between renal resistive index (RRI) and histological findings in renal biopsy in patients with lupus nephritis.
4. Assessment of the correlation between renal resistive index (RRI) and renal function parameters (BUN, S Cr and eGFR).
5. Evaluation of the role of RRI as predictor of treatment outcomes in patients with lupus nephritis.

The study will be enrolled in three steps:

The first step:comparison of renal artery resistive index(RRI) values between study group and controls.

The second step :correlation between RRI of the patients with lupus nephritis and histological findings in renal biopsy and/ or kidney function parameters (BUN ,SCr , eGFR).

The third step:the patients with lupus nephritis will be followed up for six month receiving the usual treatment according to KDIGO guidelines 2012 to demonstrate the response to treatment in patient with pathological RRI compared to with normal RRI

Conditions

• Lupus Nephritis

Interventions

DIAGNOSTIC_TEST

Doppler ultrasonography of renal arteries

Ultrasound evaluation will be performed for all patients as well as healthy individuals.in patients with lupus nephritis,the ultrasound evaluation will be performed the 24 h prior to the renal biopsy . In the maximum long-axis section images, the largest diameter and width of each kidney will be measured. The participants will be scanned in a supine or decubitus position to achieve an ultrasound beam as close to parallel to the blood flow direction in the intrarenal artery as possible. RRI is measured as : RRI = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity. the average of three measurements will be taken.

DIAGNOSTIC_TEST

Renal biopsy

Renal biopsy is a medical procedure in which a small piece of kidney is removed from the body for examination, usually under a microscope. Microscopic examination of the tissue can provide information needed to diagnose, monitor or treat problems of the kidney.Renal biopsy will be taken according American college of Romatology guidelines 2012.The renal biopsy samples were evaluated according to the Revision of the International Society of Nephrology/Renal Pathology Society classification for lupus nephritis 2017. the actvity index and chronicity index will be calculated.

DIAGNOSTIC_TEST

kidney function tests

blood sample will be taken to measure blood urea nitrogen (BUN) and serum creatinine(S Cr). estimated glomerular filtration rate (eGFR) will be measured using CKD-EPI Equation.These investigations will be done at the beginning of the study and every month for sex months for each patient to determine degree of response to treatment .

DIAGNOSTIC_TEST

The 24-hour urine protein test

The 24-hour urine protein test checks how much protein is being spilled into the urine.Urine samples are collected in one or more containers over a period of 24 hours. The containers are kept in a cool environment and then sent to a lab for analysis. Specialists then check the urine for protein.This investigations will be done at the beginning of the study and every month for sex months for each patient to determine degree of response to treatment .

DIAGNOSTIC_TEST

complete blood counting (CBC)

A complete blood count is a blood panel that gives information about the cells in a patient's blood, such as the cell count for each blood cell type and the concentrations of hemoglobin.

Sponsors & Collaborators

• Assiut University

  lead OTHER

Principal Investigators

• Ashraf A Elshazly, professor · Assiut University

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-01

Primary Completion

2021-07-01

Completion

2022-01-31