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临床试验/NCT04340999
NCT04340999已完成不适用

Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Early detection of peripheral neuropathy among liver cirrhotic patients.

研究概览

简要总结

cross sectional observational study, aimed to assess the electrophysiological function of the motor units in liver cirrhotic patients.

详细描述

Liver cirrhosis is a global health problem which could be associated with several neurological manifestations. The associated peripheral neuropathy could be assessed by conventional nerve conduction studies.

Objective

The study aims at early detection of peripheral neuropathy among patients of liver cirrhosis by conventional nerve conduction studies and quantitative EMG methods. In addition, the study aims at finding out correlation between peripheral neuropathy and severity of the liver cirrhosis.

Methods: This a cross-sectional study conducted on fifty-six liver cirrhotic patients, that had been recruited from the Endemic medicine department/outpatient clinics and their age-gender matched sixty-one healthy controls. The recruited patients were clinically assessed .Both conventional nerve conduction studies and quantitative EMG techniques in the form of MUNE calculation, using modified spike -triggered technique and IPA ratio evaluation were performed for the allocated cirrhotic patients.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders.
  • Age interval range between 18 and 60 years (To avoid maturational changes and aging process on motor unit number).
  • Liver cirrhotic patients( including compensated and decompensated patients);
  • Presenting hematemesis/melena and/or ascites.
  • Diagnosis of liver cirrhosis is confirmed by abdominal ultrasound

排除标准

  • Patients with identifiable cause of peripheral neuropathy (e.g. diabetic patients) .
  • Patients who developed hepatocellular carcinoma (to avoid para-neoplastic syndrome e.g. peripheral neuropathy)
  • Patients with other non-hepatic chronic illness such as: patients with renal disease (to avoid other causes of metabolic neuropathies).

结局指标

主要结局

Early detection of peripheral neuropathy among liver cirrhotic patients.

时间窗: baseline

* Using nerve conduction studies of the: left ulnar,left posterior tibial and right deep peroneal motor nerves;assess their distal latency (measured in milliseconds) ,amplitude (measured in millivolts) and conduction velocities (measured in m/s).In addition , to sensory studies of the left ulnar and right sural sensory nerves; assessment of peak latency (measured in milliseconds) , amplitude (measured in microvolts) and their conduction velocities(measured in m/s) . * Compare the values with our normative values. * Detect evidence of peripheral neuropathy ( increased in distal latency above the upper limit of its normal value, decreased conduction velocity below the lower limit of its normal value and decreased amplitude below lower limit of its normal value). * A minimum of three variables in two or more nerves are required to diagnose polyneuropathy as referenced by (Meulstee \& Van Der Meche , 1995).

次要结局

  • Detection of correlation between neuropathy and severity of liver cirrhosis.(baseline)
  • Motor unit number estimation using Spike-Triggered method.(Baseline)
  • Correlation of MUNE values to fatigue(Baseline)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Reem Mahmoud Mohamed Ali Gabr

Resident of Clinical neurophysiology- Kasr alainy-Cairo University

Kasr El Aini Hospital

研究点 (1)

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