Dialysis Adequacy in Nutritional Status in Hemodialysis Patients

Dialysis Adequacy Clinical Trial

Official title:

Effect of Dialysis Adequacy in Nutritional Status and Quality of Life in Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06108856
• Other study ID #: dialysis adequacy
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: george san, Bachelor's
• Phone: 01017690272
• Email: Georgesan264[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dialysis Adequacy

Intervention

Device:
• Hemodialysis machine
machine by which people undergo dialysis on it.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

Chan M, Kelly J, Batterham M, Tapsell L. Malnutrition (subjective global assessment) scores and serum albumin levels, but not body mass index values, at initiation of dialysis are independent predictors of mortality: a 10-year clinical cohort study. J Ren Nutr. 2012 Nov;22(6):547-57. doi: 10.1053/j.jrn.2011.11.002. Epub 2012 Mar 9. — View Citation

Kutsal DA, Kursat S, Inci A, Ulman C, OzanUtuk I. The relationship between malnutrition subgroups and volume parameters in pre-dialysis patients. Saudi J Kidney Dis Transpl. 2016 Jan;27(1):81-7. doi: 10.4103/1319-2442.174082. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of dialysis adequacy in nutritional status in haemodialysis patients by Body mass index (BMI) and Anthropometric measurements.	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.	baseline