Dialysis Adequacy in Nutritional Status in Hemodialysis Patients

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06108856
Collaborator
(none)
200
13

Study Details

Study Description

Brief Summary

Assess nutrition status in hemodialysis patients and effect adequacy of hemodialysis on it.

Effect of dialysis adequacy and nutritional status in patients' quality of life.

Condition or Disease Intervention/Treatment Phase
  • Device: Hemodialysis machine

Detailed Description

Patients with end-stage renal disease (ESRD) are unable to sustain life without hemodialysis. So, adequacy of hemodialysis is the main treatment for this patient.

Adequacy of hemodialysis can be appeared on patient clinically by improve Quality of life and life expectancy, increase appetite and weight gain, control blood pressure, no bone disease, control of acidosis and anemia, Relief of uremic symptoms as nausea, vomiting, fatigue, anorexia, weight loss, muscle cramps, pruritus, or changes in mental status.

Malnutrition is a major issue in patients undergoing hemodialysis and is observed in approximately 20% - 70% of this group. Malnutrition is a serious predictive factor for mortality and morbidity accompanied by an increase in the rate of hospitalization, less physical activity, lower quality of life.

An imbalance between energy and protein gain and food metabolism, metabolic acidosis, dietary restrictions, anorexia and poor appetite, protein and nutrient loss during dialysis, underlying diseases, such as cardiovascular problems, infection, poor nutrition management, inadequate dialysis, etc. are among influencing factors on the nutrition of hemodialysis patients.

Among patients undergoing hemodialysis, 6% to 8% suffer from severe malnutrition and 30% - 65% from mild malnutrition. The results of some studies have shown that one of the important causes of malnutrition is low dialysis adequacy in patients undergoing hemodialysis.

Malnutrition is associated with an increase in morbidity, a decrease in functional capacity, and a greater number and duration of hospital admissions, all of which may cause a low health-related quality of life (QOL) and impact patients' emotional, physical, and psychosocial health.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Effect of Dialysis Adequacy in Nutritional Status and Quality of Life in Hemodialysis Patients
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Effect of dialysis adequacy in nutritional status in haemodialysis patients by Body mass index (BMI) and Anthropometric measurements. [baseline]

    assess how dialysis adequacy affect nutritional status using : Body mass index (BMI) : calculated based on the weight (kg)/height (m2) formula as it divide into : underweight (BMI < 18.5) worse outcome normal weight (BMI from 18.5 to 25) better outcome . overweight (BMI = 25 - 30). obese (BMI >30) . b)Anthropometric measurements : weight in kilograms . height in meters. waist circumference in centimeters. hip circumference in centimeters. mid arm circumference in centimeters.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients in regular haemodialysis .

  2. patients above 18 years

Exclusion Criteria:
  1. Patients with thyroid illness.

  2. Patients with acute infection.

  3. Patients with major surgeries.

  4. Patients with malignancy.

  5. Patients with liver cirrhosis.

  6. patient with inflammatory bowel diseases.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
George san dawoud bebawy, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT06108856
Other Study ID Numbers:
  • dialysis adequacy
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 31, 2023