Malnutrition Chronic hemodialysis Intradialytic Postdialytic Oral nutritional supplement Malnutrition Chronic hemodialysis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Receiving maintenance hemodialysis for more than 6 months, with dialysis performed three times per week for approximately 4 hours per session 2. Adequate dialysis, defined as a delivered single pool KtV more than or equal to 1.2 3. Malnutrition Inflammation Score (MIS) more than or equal to 6, or serum albumin less than 3.8 g/dL
Exclusion criteria
Exclusion criteria: 1. Active malignancy 2. Advanced liver disease 3. Cognitive impairment 4. A history of allergy to any component of the oral nutritional supplement used in the study 5. Frequent intradialytic hypotension, defined as a nadir intradialytic systolic blood pressure (SBP) less than 90 mmHg on more than three occasions within the month before study enrollment 6. Presence of intestinal obstruction or a gastrointestinal disorder affecting nutrient absorption 7. A history of hospitalization or major surgery within 3 months before study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in dialysis adequacy baseline and 12-week measurement spKt/V | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum albumin level baseline and 12-week measurement Serum albumin,Change in Malnutrition Inflammation Score baseline and 12-week measurement MIS,Change in muscle mass baseline and 12-week measurement Bioimpedance,Change in health related quality of life baseline and 12-week measurement KDQOL SF v1.3,Change in inflammatory biomarkers baseline and 12-week measurement CRP,Safety baseline and 12-week measurement Intradialytic hypotension events | — |
Countries
Thailand
Contacts
Division of Nephrology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University