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临床试验/NCT03958851
NCT03958851Unknown不适用

Measurement of Renal Artery Resistive Index as a Predictor of Severity of Lupus Nephritis and Its Response to Treatment

Assiut University0 个研究点目标入组 120 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
The mean of renal artery resistive(RRI) in each group

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 30 minutes

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

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

时间窗: 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

次要结局

  • Correlation between renal artery resistive index (RRI) and renal function parameters (BUN, SCr and eGFR) in patients with lupus nephritis(two hours)
  • The mean of renal artery resistive index in each histological class in renal biopsy(one weak)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasser Abd Elmawgood Fysal Ibrahim

assistant lecturer

Assiut University

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