跳至主要内容
临床试验/NCT03990142
NCT03990142已完成不适用

Study of Abnormalities of the Vegetative Nervous System in the Occurrence of Intradialytic Arterial Hypotension

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2019年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
1
主要终点
Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis

研究概览

简要总结

Intradialytic hypotension is a common complication of hemodialysis sessions in patients with chronic renal failure, with an estimated prevalence of 10 to 30%. This hypotensopn is classically defined by a decrease in systolic blood pressure greater than 30 mmHg associated with clinical signs (cramps, abdominal pain, unconsciousness, convulsions). Its repetition is correlated with cardiovascular events, neurological events and excess mortality. Several clinical factors have been proposed to predict the risk of intradialytic hypotension such as age, certain comorbidities (diabetes, ischemic heart disease...), dialysis modalities (hemodialysis), ultrafiltration, conductivity but also alterations of the autonomic nervous system (especially the sympathetic system).

In recent years, the study of vegetative functions has been facilitated by the use of SUDOSCAN® (Impeto, Paris, France) which is a simple, non-invasive tool that allows the study of Chlorine conductance directly reflecting the activity of small non-myelinated C fibers that innervate the sweat glands. SUDOSCAN® has shown good sensitivity and specificity in the diagnosis of vegetative damage in diabetic patients and also a good correlation with cardiac autonomic neuropathy. More recently, SUDOSCAN® has shown good sensitivity in the detection of neuropathies small fibers especially in diabetic patients. This sensitivity is comparable to QST-type quantitative tests and the correlation with cardiovascular dysautonomia tests is good. This test, simple and fast realization, does not require the active participation of the patient. There is a good correlation between the results of SUDOSCAN® and the reduction of intra-dermal fiber density at cutaneous biopsy.

Hemodialysis patients are at risk of peripheral neurological involvement not only because of an increasing incidence of diabetes (30-40%) but also because of the abnormal production and elimination of certain uremic toxins. Few studies exist on the anomalies of the vegetative system in hemodialysis. A recent publication has suggested a difference in nerve excitability depending on the type of hemodialysis suggesting nerve changes secondary to ionic changes. The identification of patients at risk of intradialytic hypotension during dialysis sessions could be useful for adapting hemodialysis protocols.

Patients will be classified into 2 groups according to the occurrence of intradialytic hypotension. Group 1 corresponds to patients with intradialytic hypotension and group 2 corresponds to patients without intradialytic hypotension.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Patient whose age ≥ 18 years
  • •Patient on hemodialysis for more than 6 months
  • •Patient affiliated with a health insurance plan
  • •Francophone patient
  • •Patient giving free, informed and express consent

排除标准

  • •Patient with lesions, wounds, amputations preventing the measurement of the chlorine conductance of the palms of the hands and feet
  • •Patient with a disability that prevents them from standing while measuring conductance / SUDOSCAN®
  • •Patient already included in an interventional research protocol
  • •Patient under tutorship or curatorship
  • •Patient deprived of liberty

研究组 & 干预措施

Group 1: patients without intradialytic hypotension

Experimental

The investigators will measure the cutaneous conductance to chlorine by SUDOSCAN® in all dialysis patients without intradialytic hypotension and to seek a link between the results of this examination and the occurrence of discomfort during hemodialysis sessions.

干预措施: Cutaneous conductance to chlorine by SUDOSCAN (Diagnostic Test)

Group 2: patients with intradialytic hypotension

Experimental

The investigators will measure the cutaneous conductance to chlorine by SUDOSCAN® in all dialysis patients with intradialytic hypotension and to seek a link between the results of this examination and the occurrence of discomfort during hemodialysis sessions.

干预措施: Cutaneous conductance to chlorine by SUDOSCAN (Diagnostic Test)

结局指标

主要结局

Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis

时间窗: Day 1

This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts before hemodialysis.

次要结局

  • Cutaneous conductance to chlorine by SUDOSCAN after hemiodialysis(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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