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临床试验/NCT05797766
NCT05797766已完成3 期

Efficacy of Fluid Distribution Timetable on the Treatment Adherence of End-Stage Renal Disease Patient: A Randomized Controlled Trial

University of Santo Tomas2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月18日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Intradialytic Weight Gain

研究概览

简要总结

Nonadherence to fluid restriction is a significant issue among hemodialysis patients globally, with numerous adverse health outcomes. These outcomes include increased intradialytic weight gain, acid-base and electrolyte imbalances, and decreased mental health. This study aimed to determine the effects of a fluid distribution timetable on adherence to fluid restriction among patients with end-stage renal disease undergoing hemodialysis. The study utilized a single-blind, randomized-controlled efficacy trial design. Selected ESRD patients undergoing hemodialysis are then randomized using computer-generated sequences of randomly permuted blocks stratified according to sex to receive the intervention or the control group. Adherence to fluid restriction was measured using the dialysis thirst inventory and intradialytic weight gain. The variables were computed using One-way Repeated Measures Multivariate Analysis of Variance and Multivariate Analysis of Covariance. Secondary outcomes included baseline patient demographic profile and was compared according to group allocation. Both group were followed up for four weeks, assessing the outcome measures during the third hemodialysis session for each week

详细描述

Chronic Kidney Disease (CKD), a condition wherein the kidney is damaged and cannot filter blood properly (National Institute of Diabetes and Digestive and Kidney Diseases, 2019), if left untreated, end-stage renal disease (ESRD) otherwise known as kidney failure occurs. CKD has been recognized as one of the major public health problems globally and has an estimated prevalence of 13.4% of the total population and ESRD has an estimate between 4.902 million to 7.083 million cases. According to the CKD Health Policy Model, it is projected that there would be an increase of 16.7% cases of CKD in adults in the year 2030.

Hemodialysis is a maintenance management form of renal replacement therapy. It is a treatment to filter the excess fluid and blood wastes by using a special filter that is considered as an artificial kidney. However, hemodialysis alone is not a treatment for this disease, with the help of fluid restriction and change of dietary prescription the quality of life of the patient may significantly improve.

In the perspective of hemodialysis patients, adherence to dietary regimens and fluid restrictions is a great challenge due to the burden of constant choices about food and drink, the adaptation to complex eating patterns, existing cultural practices, and the competing demands of the chronic disease and comorbidities.

Adherence to fluid restriction is a major problem among hemodialysis patients around the world and persists to be a clinical concern in nephrology care. and a clinical problem in nephrology care. Nonadherence to fluid restriction as defined by the National Kidney Foundation is gaining an intradialytic weight of more than 5.7% of their weight post hemodialysis session. Nonadherence to fluid restriction are found to have numerous health-related problems, an increased intradialytic weight gain, acid-base and electrolyte imbalances, and a decrease in mental health. Other than themselves, the hemodialysis patient must also consider the burden of their home caregivers such as the management of family costs, the maintenance of physical and psychological health, the provision of care, the assumption of multiple roles, and the communication of expectations are challenges as a caregiver.

This study is a single-blind, single center, randomized-controlled trial that utilized data collection triangulation to assess the efficacy and feasibility of a nursing intervention that will promote treatment adherence to fluid restriction among hemodialysis patients in a private tertiary level institution in Manila, Philippines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Diagnosed with End-stage renal disease
  • Oliguric (urine output of less than 20ml/ hr)
  • Aged 40 - 70 years old
  • Had been on dialysis for at least 6 months
  • Is alert and oriented
  • With scheduled for hemodialysis thrice a week.

排除标准

  • Pregnant patients
  • Has a history or overt mental illness
  • Patients with congestive heart failure

结局指标

主要结局

Intradialytic Weight Gain

时间窗: 4 Weeks

It is the net increase in body weight from previous post-dialysis weight measured in kilograms

Perceived Thirst Score

时间窗: 4 Weeks

The Dialysis Thirst Inventory (DTI) measured perceived thirst among the participants. It is a 7-item questionnaire answered on 5-point Likert scale, with scores ranging from 7 to 35 and higher scores indicating higher thirst. No cut-off score is present for the questionnaire; however, higher scores are interpreted as higher perceived thirst.

次要结局

  • Sex(Week 1)
  • Educational Attainment(Week 1)
  • Age(Week 1)
  • Edema Status(Week 1)
  • Ultrafiltration Goal(Week 1)

研究者

发起方
University of Santo Tomas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Nathaniel Ellano

Principal Investigator

University of Santo Tomas

研究点 (2)

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