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

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ClinicalTrials.gov Identifier: NCT03958851
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Yasser Abd Elmawgood Fysal Ibrahim, Assiut University

Brief 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


Condition or disease Intervention/treatment
Lupus Nephritis Diagnostic Test: Doppler ultrasonography of renal arteries Diagnostic Test: Renal biopsy Diagnostic Test: kidney function tests Diagnostic Test: The 24-hour urine protein test Diagnostic Test: complete blood counting (CBC)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Measurement of Renal Artery Resistive Index as a Predictor of Severity of Lupus Nephritis and Its Response to Treatment
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
patients with lupus nephritis
Lupus nephritis is diagnosed by either the presence of proteinuria (>0.5 g/day), active urinary sediment (with red blood cell, granular, tubular and/or mixed casts), or an unexplained rise in serum creatinine in patients with systemic lupus.
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.

systemic lupus patients without lupus nephritis
The diagnosis of SLE will be according to the 1997 American college of Romatology revised criteria (Hochberg 1997).these group will be taken as a control group
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.


healthy individuals
a group of age and sex matched healthy individuals will be taken as a control group.
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.





Primary Outcome Measures :
  1. The mean of renal artery resistive(RRI) in each group [ Time Frame: 30 minutes ]
    the sum of RRI values in each group divided by the number of individuals in each group

  2. Correlation between Renal Resistive Index and chronicity index in renal biopsy of patients with Lupus Nephritis [ Time Frame: one weak ]
    Renal Resistive Index will be measured as :RRI = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity .chronicity index score in renal biopsy will be calculated according to the Revision of the International Society of Nephrology/Renal Pathology Society classification for lupus nephritis 2017. Result of renal biopsy will be reported within one weak.Correlation between RRI and chronicity index using correlation tests using SPSS version 20; pearson correlation test if the data are normally distributed and spearman correlation test if the data aren't normally distributed


Secondary Outcome Measures :
  1. The mean of renal artery resistive index in each histological class in renal biopsy [ Time Frame: one weak ]
    pathological RRI(RRI>0.7) .Renal biopsy will be evaluated according to the Revision of the International Society of Nephrology/Renal Pathology Society classification for lupus nephritis 2017. There are 6 classes of lupus nephritis in renal biopsy. Number of patients in each class will be identified. the sum of RRI values in each class divided by the number of patients in each class

  2. Correlation between renal artery resistive index (RRI) and renal function parameters (BUN, SCr and eGFR) in patients with lupus nephritis [ Time Frame: two hours ]
    measurement of RRI in each patient with lupus nephritis . Blood sample from the same patient to measure blood urea nitrogen (BUN), serum creatinine(S Cr) and estimated glomerular filtration rate (eGFR) (using CKD-EPI Equation)

  3. Correlation between renal artery resistive index and response to treatment in patients with lupus nephritis [ Time Frame: 6months ]
    RRI will be measured for every patient with lupus nephritis at the beginning of the study. the patients will be followed for 6 months .BUN,S Cr , eGFR and and 24 h urinary protein excretion will be measured at the beginning of the study and every month for sex months to determine degree of response to treatment in patients with pathological RRI(0.7) compared to those with normal RRI.

  4. Correlation between RRI and mean of hemoglobin level in patients with lupus nephritis. [ Time Frame: 6 months ]
    RRI will be measured for every patient of lupus nephritis at the beginning of the study.Hemoglobin level will be measured at the beginning of the study and every month for sex months and the mean will be calculated



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. All patients with lupus nephritis that will be admitted in internal medicine department from August 2019 to January 2021 .
  2. All patients with systemic lupus erythematosus(SLE) without renal affection, that will be admitted in internal medicine department from August 2019 to January 2021 .
  3. A group of age and sex matched healthy individuals. The first group is the study group while the second and third groups group will be taken as control group

Exclusion Criteria:

  1. chronic renal failure
  2. Diabetes mellitus
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958851


Contacts
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Contact: yasser A fysal, Master +201012872076 y.fysal89@aun.edu.eg
Contact: Adel H Mekawy, Ph.D. +201064347436 Adelmek69@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Ashraf A Elshazly, professor Assiut University

Publications of Results:
Other Publications:
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Responsible Party: Yasser Abd Elmawgood Fysal Ibrahim, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03958851     History of Changes
Other Study ID Numbers: RRI in lupus nephritis
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasser Abd Elmawgood Fysal Ibrahim, Assiut University:
renal resistive index
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases