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

NCT03958851 | Unknown

• 1 other identifier: RRI in lupus nephritis
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

Lupus Nephritis

Keywords

renal resistive index

Outcome Measures

Primary Outcomes (2)

• The mean of renal artery resistive(RRI) in each group

  the sum of RRI values in each group divided by the number of individuals in each group

  30 minutes

• Correlation between Renal Resistive Index and chronicity index in renal biopsy of patients with Lupus Nephritis

  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

  one weak

Secondary Outcomes (4)

• The mean of renal artery resistive index in each histological class in renal biopsy

  one weak

• Correlation between renal artery resistive index (RRI) and renal function parameters (BUN, SCr and eGFR) in patients with lupus nephritis

  two hours

• Correlation between renal artery resistive index and response to treatment in patients with lupus nephritis

  6months

• Correlation between RRI and mean of hemoglobin level in patients with lupus nephritis.

  6 months

Study Arms (3)

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; Diagnostic Test: Renal biopsy; Diagnostic Test: kidney function tests; Diagnostic Test: The 24-hour urine protein test; Diagnostic Test: complete blood counting (CBC)

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

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

Interventions

Doppler ultrasonography of renal arteries DIAGNOSTIC_TEST

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; patients with lupus nephritis; systemic lupus patients without lupus nephritis

Renal biopsy DIAGNOSTIC_TEST

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.

patients with lupus nephritis

kidney function tests DIAGNOSTIC_TEST

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 .

patients with lupus nephritis

The 24-hour urine protein test DIAGNOSTIC_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 .

patients with lupus nephritis

complete blood counting (CBC) DIAGNOSTIC_TEST

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.

patients with lupus nephritis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• All patients with lupus nephritis that will be admitted in internal medicine department from August 2019 to January 2021 .
• All patients with systemic lupus erythematosus(SLE) without renal affection, that will be admitted in internal medicine department from August 2019 to January 2021 .
• 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

You may not qualify if:

• chronic renal failure
• Diabetes mellitus
• Obstructive nephropathy
• Renal artery stenosis
• Hypertension
• Heart failure
• Hepatic diseases.
• Existing intra renal A-V fistula.
• Renal vein thrombosis.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Boddi M, Natucci F, Ciani E. The internist and the renal resistive index: truths and doubts. Intern Emerg Med. 2015 Dec;10(8):893-905. doi: 10.1007/s11739-015-1289-2. Epub 2015 Sep 4.

  PMID: 26337967 BACKGROUND

• Krumme B. Renal Doppler sonography--update in clinical nephrology. Nephron Clin Pract. 2006;103(2):c24-8. doi: 10.1159/000090605. Epub 2006 Mar 10.

  PMID: 16543752 BACKGROUND

• Hahn BH, McMahon MA, Wilkinson A, Wallace WD, Daikh DI, Fitzgerald JD, Karpouzas GA, Merrill JT, Wallace DJ, Yazdany J, Ramsey-Goldman R, Singh K, Khalighi M, Choi SI, Gogia M, Kafaja S, Kamgar M, Lau C, Martin WJ, Parikh S, Peng J, Rastogi A, Chen W, Grossman JM; American College of Rheumatology. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):797-808. doi: 10.1002/acr.21664. No abstract available.

  PMID: 22556106 BACKGROUND

• Rees F, Doherty M, Grainge MJ, Lanyon P, Zhang W. The worldwide incidence and prevalence of systemic lupus erythematosus: a systematic review of epidemiological studies. Rheumatology (Oxford). 2017 Nov 1;56(11):1945-1961. doi: 10.1093/rheumatology/kex260.

  PMID: 28968809 BACKGROUND

• Chen Q, He F, Feng X, Luo Z, Zhang J, Zhang L, Wang Y, Tong J. Correlation of Doppler parameters with renal pathology: A study of 992 patients. Exp Ther Med. 2014 Feb;7(2):439-442. doi: 10.3892/etm.2013.1442. Epub 2013 Dec 10.

  PMID: 24396421 RESULT

• Corapi KM, Dooley MA, Pendergraft WF 3rd. Comparison and evaluation of lupus nephritis response criteria in lupus activity indices and clinical trials. Arthritis Res Ther. 2015 Apr 28;17(1):110. doi: 10.1186/s13075-015-0621-6.

  PMID: 25927414 RESULT

• Tao JL, Li H, Li C, Xu XW, Li JF, Yi N, Liu DY, Qin Y, Cai JF, Liu BY, Xu H, Gao RT, Ye WL, Ye W, Li XM, Li XW. [Risk factors of post-renal biopsy bleeding]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2008 Jun;30(3):313-7. Chinese.

  PMID: 18686612 RESULT

• Sugiura T, Nakamori A, Wada A, Fukuhara Y. Evaluation of tubulointerstitial injury by Doppler ultrasonography in glomerular diseases. Clin Nephrol. 2004 Feb;61(2):119-26. doi: 10.5414/cnp61119.

  PMID: 14989631 RESULT

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Kidney Function Tests

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ashraf A Elshazly, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

yasser A fysal, Master

CONTACT

+201012872076; y.fysal89@aun.edu.eg

Adel H Mekawy, Ph.D.

CONTACT

+201064347436; Adelmek69@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: January 1, 2022
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share