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 :
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 |
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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) |
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 |
Group/Cohort | Intervention/treatment |
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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.
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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.
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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
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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.
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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. |
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: yasser A fysal, Master | +201012872076 | y.fysal89@aun.edu.eg | |
Contact: Adel H Mekawy, Ph.D. | +201064347436 | Adelmek69@yahoo.com |
Study Director: | Ashraf A Elshazly, professor | Assiut University |
Tracking Information | |||||||||
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First Submitted Date | May 20, 2019 | ||||||||
First Posted Date | May 22, 2019 | ||||||||
Last Update Posted Date | May 24, 2019 | ||||||||
Estimated Study Start Date | August 1, 2019 | ||||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Renal Resistive Index as a Marker of Severity and Treatment Outcomes in Lupus Nephritis | ||||||||
Official Title | Measurement of Renal Artery Resistive Index as a Predictor of Severity of Lupus Nephritis and Its Response to Treatment | ||||||||
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 :
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 |
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Detailed Description |
LN is known to be one of the most serious complications of SLE and it is the major predictor of poor prognosis. In the United States, approximately 35% of adults with SLE have clinical evidence of nephritis at the time of diagnosis; with an estimated total of 50 to 60% developing nephritis during the first 10 years of disease. 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 (S Cr). A kidney biopsy is the gold standard to diagnose LN as it provides information regarding the pattern and severity of renal involvement as well as the stage, activity and chronicity. These are all important considerations influencing treatment decisions. However, the invasive nature make it contraindicated in certain situation like bleeding tendency. In one report, five of seven patients with significant bleeding after renal biopsy were patients with LN. Serial biopsy may be needed to monitor progression and treatment. This will increase risk of complication and may be not practical. The renal arterial resistive index (RRI) is a sonographic index to assess for renal arterial disease. It is measured as: RRI = (peak systolic velocity - end diastolic velocity) / peak systolic velocity .The RRI was introduced in 1950, and was initially proposed for the semi-quantitative assay of intra-renal vascular resistance by Gosling and Pourcelot in 1974. RRI is and markedly affected by renal determinants such as renal interstitial and venous pressure. In humans in vivo, the acute increase of renal interstitial pressure by hydronephrosis or of venous pressure by venous thrombosis, or of both by abdominal hypertension, results in a linearly related increase in RRI. Increases in the RRI have been observed in a number of pathological conditions, which increase renal interstitial and venous pressure such as renal allograft acute rejection, parenchymal nephropathies, acute kidney injury, renal artery stenosis, chronic kidney disease (CKD), diabetic nephropathy, obstructive nephropathy. Remarkably, interstitial fibrosis closely correlates to renal function and long term prognosis, and may underlie the role of RRI as an independent marker of renal and clinical outcome in chronic renal diseases. No standard, validated, cut-off to distinguish normal from high RRI has been identified to date. RRI values between 0.7 and 0.85 have been associated with renal functional impairment in patients with chronic kidney disease and stenosis of the renal artery. Previous data have revealed a significant correlation between the increased RRI value (RRI>0.7) and renal functional parameters (creatinine and blood urea nitrogen levels) and/or histological finding, such as glomerulosclerosis, tubulointerstitial damage and vascular lesions. Few studies evaluate the role of RRI as marker of severity in LN and its potential use as non-invasive marker in the assessment of the outcomes and in treatments response. To date, the usefulness of RRI in monitoring the progression and treatment of LN is controversial. Type of the study: : observational analytic cross sectional study - cohort study (the part of the study in which the patients of LN are followed for six month receiving the usual treatment according to KDIGO( Kidney Disease: Improving Global Outcomes) guidelines 2012 to demonstrate the response to treatment in patient with pathological RRI compared to with normal RRI) - Study Setting: Assiut University Hospital (internal medicine departments) 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 . Sample Size technique: total coverage The ratio of controls to study group will be 2:1. Study methods: A-The study group will be subjected to:-
B-The control group (non renal SLE patients and healthy individuals) will be subjected to history taking, physical examination and Doppler ultrasonography as the same as the study group. Aims of the work:
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Study Type | Observational | ||||||||
Study Design | Observational Model: Other Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
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. | ||||||||
Condition | Lupus Nephritis | ||||||||
Intervention |
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Not yet recruiting | ||||||||
Estimated Enrollment |
120 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | January 2022 | ||||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03958851 | ||||||||
Other Study ID Numbers | RRI in lupus nephritis | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Yasser Abd Elmawgood Fysal Ibrahim, Assiut University | ||||||||
Study Sponsor | Assiut University | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Assiut University | ||||||||
Verification Date | May 2019 |