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临床试验/NCT04274556
NCT04274556已完成不适用

Do Biochemical Parameters and Intradialytic Symptoms Affect Post-dialysis Recovery Time?: A Cross-sectional Study

Istanbul Demiroglu Bilim University2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年6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
86
试验地点
2
主要终点
Post-dialysis Recovery Time

研究概览

简要总结

Patients undergoing hemodialysis (HD) can experience symptoms such as lassitude, pain, muscle cramps, nausea, vomiting, constipation, diarrhea, rash, skin dryness, sleep disorders, and emotional and sexual problems after the treatment. Many chronic HD patients do not feel well after the treatment sessions and need some time to recover. This recovery time is defined as the time required to recover from the feelings of lassitude and fatigue.

详细描述

The recovery time not only decreases the quality of life but also increases the risk of mortality and morbidity. As a prolonged recovery time affects both the patients and the healthcare professionals and caregivers, there has been increased interest on determining the modifiable treatment-related factors in the international literature. The patients are limited in their daily living activities at home and at work during this period and a significant amount of time is therefore required to go back to normal life.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Being on HD for 4 hours a day on 3 days per week for at least 6 months
  • No communication problem
  • Volunteering to participate to the study

排除标准

  • Younger than 18 years
  • Shorter being on HD for 4 hours a day on 3 days per week for at least 6 months
  • Have communication problem
  • Not volunteering to participate to the study

结局指标

主要结局

Post-dialysis Recovery Time

时间窗: Up to 7 days

Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.

Number of Participants With Intradialytic Hypotension

时间窗: Up to 7 days

It is defined in the European Best Practice Guideline (EBPG) as a decrease of 20 mmHg or more in the systolic blood pressure or 10 mmHg or more in the mean arterial blood pressure together with symptoms requiring nursing intervention.

Rate of Dialysis Symptoms

时间窗: Up to 7 days

It was identified with Dialysis Symptom Index (DSI). DSI consists of 30 items. We queried the subjects regarding symptoms in the last 7 days. The effect was evaluated with a Likert type scale from 0 to 4, representing "not at all" to "significantly". The total score of the DSI ranges from 0 to 150. A score of zero reflects no symptoms while increasing total scores reflect increasing effects of the symptoms.

次要结局

未报告次要终点

研究者

发起方
Istanbul Demiroglu Bilim University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurten Ozen

Assistant Professor

Istanbul Demiroglu Bilim University

研究点 (2)

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