跳至主要内容
临床试验/CTRI/2024/07/071029
CTRI/2024/07/071029尚未招募不适用

Evaluation of Nutritional status in patients undergoing maintenance hemodialysis in a rural tertiary care hospital in Central India

未提供1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
1. Prevalence of Malnutrition in Patients Undergoing MHD:

研究概览

简要总结

This study aims to evaluate the nutritional status of patients undergoing maintenance hemodialysis (MHD) in a rural tertiary care hospital in central India, addressing the high prevalence of malnutrition, particularly protein-energy malnutrition (PEM), among this population. Conducted over 1.5 years at Acharya Vinoba Bhave Rural Hospital, the study involves 200 participants and employs the Modified Quantitative Subjective Global Assessment (MQSGA) tool to assess nutritional status. The primary outcomes include the prevalence and changes in malnutrition status, while secondary outcomes focus on anthropometric measurements, biochemical markers, dietary intake, quality of life, and hospitalization and mortality rates. This research underscores the critical need for routine nutritional assessments in MHD patients to enhance their quality of life and survival, providing valuable insights into effective nutritional screening and management practices in the Indian healthcare context.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Age more than 18 years
  • Patient should have been on regular haemodialysis for at least 3 months.

排除标准

  • Age less than 18 years
  • patients with active infection at the time of study
  • history of admission to the hospital in the past three months
  • alcoholism
  • acute renal failure
  • major adverse cardiovascular events
  • severe gastrointestinal and hepatic diseases
  • Poor compliance with dialysis treatment, defined as skipping more than one session of haemodialysis in the preceding 4 weeks.

结局指标

主要结局

1. Prevalence of Malnutrition in Patients Undergoing MHD:

时间窗: At the time of enrollment, mid-study (6 months), and at the end of the study (1.5 years).

- Measure: Percentage of patients categorized into different nutritional status groups (normal nutrition, mild-to-moderate malnutrition, severe malnutrition) using the Modified Quantitative Subjective Global Assessment (MQSGA) tool.

时间窗: At the time of enrollment, mid-study (6 months), and at the end of the study (1.5 years).

2. Change in Nutritional Status Over Time:

时间窗: At the time of enrollment, mid-study (6 months), and at the end of the study (1.5 years).

- Measure: Change in MQSGA scores from baseline to follow-up points.

时间窗: At the time of enrollment, mid-study (6 months), and at the end of the study (1.5 years).

次要结局

  • 1. Anthropometric Measurements:(-Measure: Changes in body mass index (BMI), mid-arm circumference (MAC), mid-arm muscle circumference (MAMC), triceps skin fold (TSF), & biceps skin fold (BSF).)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Pranjal Kashiv

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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