Clinical trial NCT06108856: Dialysis Adequacy in Nutritional Status in Hemodialysis Patients
Official title: Effect of Dialysis Adequacy in Nutritional Status and Quality of Life in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dialysis Adequacy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient on regular hemodialysis above 18 years without acute infection, major surgeries, recent trauma, or liver cirrhosis.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of dialysis adequacy in nutritional status in haemodialysis patients by Body mass index (BMI) and Anthropometric measurements.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.