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临床试验/NCT03870594
NCT03870594Unknown不适用

Intradialytic Hypotension in Diabetic Haemodialysis Patients and Its Association With Dialytic Age

Mahmoud Mohamed Fawzy0 个研究点目标入组 90 人开始时间: 2019年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
主要终点
the correlation between dialytic age and intradialytic hypotension

研究概览

简要总结

Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis .Diabetes is associated with autonomic neuropathy which contribute to intradialytic hypotension

详细描述

Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis.Intradialytic hypotension is a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms like cramps, dizziness, headache ,nausea and vomiting according to The National Kidney Foundation.Intradialytic hypotension occurs during 20%-30% of hemodialysis sessions. It is associated with poor long-term outcomes. Patients with Intradialytic hypotension show increased morbidity and mortality.The etiology of Intradialytic hypotension is multifactorial and depends on patient-related factors, as well as on complications related to the dialysis procedure. The main causes Intradialytic hypotension have been reported to be acute hypovolemia during ultrafiltration and inadequate compensatory mechanisms such as left ventricular dysfunction, inappropriate plasma refilling ,Impaired vasoconstriction induced by dysregulation of autonomic nervous system.

Diabetes mellitus is the most common cause of chronic renal failure .Diabetic patients are more prone to cardiovascular diseases than non-diabetics .Although diabetes is in relation with hypertension ,It is associated with autonomic neuropathy which contribute to intradialytic hypotension . Recent researches suggested that older age and long dialytic age may incease risk of intradialytic hypotension.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital

排除标准

  • 1-Advanced heart failure 2-Clinical instability requiring hospital admission. 3-History of alcohol or substance abuse 4-previous history of psychotic disorders

结局指标

主要结局

the correlation between dialytic age and intradialytic hypotension

时间窗: 4 weeks

Prior to the dialysis session,full history taking including age,duration of haemodialysis Blood pressure (BP) will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions. Intradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms

the correlation between diabetes and intradialytic hypotension

时间窗: 4 weeks

Blood samples will be obtained for glycated hemoglobin, fasting blood glucose.Then patients will be divided into two groups DM, non DM. Blood pressure will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions.Intradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms

次要结局

未报告次要终点

研究者

发起方
Mahmoud Mohamed Fawzy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mahmoud Mohamed Fawzy

resident doctor at health insurance hospital ,Assiut, Egypt

Assiut University

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