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临床试验/NCT04943081
NCT04943081Unknown不适用

The Effect of Percutaneous Nephrolithotomy on the Estimated Glomerular Filtration Rate in Patients With Stage 2-4 Chronic Kidney Disease

Assiut University0 个研究点目标入组 50 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Estimation of GFR for all patients three months post-operative

研究概览

简要总结

The study aims to evaluate the effect of percutaneous nephrolithotomy (PCNL) on estimated glomerular filtration rate (eGFR) in patients with stage 2-4 chronic kidney disease

详细描述

Nephrolithiasis affects an estimated 5-10% of the general population, and this percentage continues to rise. It has a prevalence of 1.7% to 18% in patients with chronic kidney disease (CKD), and nephrolithiasis-related CKD contributed to 3.2% of the total patients who started maintenance dialysis therapy.

The etiology of renal insufficiency in patients with nephrolithiasis is multifactorial and includes renal obstruction, recurrent urinary tract infections, frequent surgical interventions and coexisting medical disease.

According to National kidney foundation, chronic kidney disease is classified into 5 stages as follows:

Stage 1: Kidney damage with normal or elevated GFR < 90 ml/min/1.7 m2 Stage 2: Kidney damage with mildly decreased GFR 60-89 ml/min/1.7 m2 Stage 3: Moderately decreased GFR 30-59 ml/min/1.7 m2 Stage 4: Severely decreased GFR 15-29 ml/min/1.7 m2 Stage 5: Kidney Failure GFR>15 ml/min/1.7 m2 Management of nephrolithiasis in patients with CKD is often difficult. Options for preserving kidney function include watchful waiting, shockwave lithotripsy (SWL), an endourologic approach (Percutaneous nephrolithotomy or retrograde intra-renal surgery), laparoscopic surgery or conventional open surgery.

Percutaneous nephrolithotomy (PCNL) is considered as the gold standard intervention for large burden and complex renal stone disease and is associated with the highest stone free rates (SFRs). However, potentially significant complications include bleeding, sepsis, pleural and visceral injury. Therefore, the optimal management plan needs to be tailored to individual patient.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL with pre-operative estimated GFR less than 90 ml/min/1.7 m2 and ≥ 15 ml/min/1.7 m2

排除标准

  • Patients with chronic renal failure on regular dialysis.
  • Patients with bleeding diathesis.
  • Patients who are unfit for surgery.
  • Pregnancy
  • Patients who are refusing the participation in our study.

结局指标

主要结局

Estimation of GFR for all patients three months post-operative

时间窗: 3 months post-operative

Estimation of GFR for all patients three months post-operative by using body surface area based-Cockcroft-Gault formula (CG/ BSA). Body surface area based Cockcroft-Gault formula (CG/ BSA) = \[(140- age) x weight in kilograms x (0.85 if female)\] / (72 x serum creatinine in mg/dl). This formula expects weight to be measured in kilograms and creatinine to be measured in mg/dl.

Estimation of GFR for all patients pre-operative

时间窗: 1 day pre-operative

Estimation of GFR for all patients pre-operative by using body surface area based-Cockcroft-Gault formula (CG/ BSA). Body surface area based Cockcroft-Gault formula (CG/ BSA) = \[(140- age) x weight in kilograms x (0.85 if female)\] / (72 x serum creatinine in mg/dl). This formula expects weight to be measured in kilograms and creatinine to be measured in mg/dl.

次要结局

未报告次要终点

研究者

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

Mohamed Abdelghany Allam

Assistant lecturer

Assiut University

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