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Effectiveness and safety of the intradialytic oral nutrition over nutritional markers and intradialytic hypotension in comparison with home complementation in patients undergoing hemodialysis

Effectiveness and safety of the intradialytic oral nutrition over nutritional markers and intradialytic hypotension in comparison with home complementation in patients undergoing hemodialysis: a noninferiority equivalence randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14815010
Enrollment
70
Registered
2017-07-13
Start date
2017-11-28
Completion date
Unknown
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Not Applicable

Interventions

Simple random allocation according to shift-day treatment for hemodialysis (HD) session. Both groups will consume a liquid renal specific supplement which grants 19 grams of protein and 434 Kcal per 2

Sponsors

National Institute of Medical Science and Nutrition Salvador Zubirán
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Chronic hemodialysis (> 3 months) 2. Program of 3 sessions per week 3. Adults aged 18-65 4. Kt/V > 1.2 or URR > 65% 5. Agree to participate and informed consent

Exclusion criteria

Exclusion criteria: 1. Amputee of any extremity 2. Renal transplant within 3 next months 3. HD as treatment for kidney injury 4. Hospitalization at least one month prior to the initiation of the study

Design outcomes

Primary

MeasureTime frame
Incidence of intradialytic hypotension, obtained from the nurse sheet at 60, 90, 120, 150, 180, 210, 240 minutes of HD sessions

Secondary

MeasureTime frame
1. Sleep quality, analysed using Pittsburgh scale applied by a trained professional at the beginning and at the end of the intervention 2. Muscle strength, analysed using a dynamometer, requesting patients to press it as hard as they can after HD treatment. The measurement will be registered for 3 times on each arm 3. Calorie-protein intake, measured with a 3-day dietary register. Each patient will register their food consumption during 3 days: 1) HD day, 2) No HD session weekday and 3) Weekend day. Data will be analyzed by dietary software 4. Phase angle, determined with multifrequency BIA device after HD session 5. Incidence of nausea, vomiting, cramps, obtained from the nurse sheet (present/absent) at 60, 90, 120, 150, 180, 210, 240 minutes of HD sessions

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026