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

• Register: ISRCTN
• Last refreshed on: 22 August 2022
• Main ID: ISRCTN14815010
• Date of registration: 13/07/2017
• Prospective Registration: Yes
• Primary sponsor: National Institute of Medical Science and Nutrition Salvador Zubirán
• Public title: Effectiveness and safety of the intradialytic oral nutrition over nutritional markers and intradialytic hypotension in comparison with home complementation in patients undergoing hemodialysis
• Scientific title: 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
• Date of first enrolment: 28/11/2017
• Target sample size: 70
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14815010
• Study type: Interventional
• Study design: Randomized controlled clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Mexico

Contacts

• Name: María de los Ángeles Espinosa Cuevas

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Hemodialysis
Not Applicable

Intervention(s)

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 237 ml:
1. The intervention group will consume 120 ml at minutes 60-75 and 210-225 of a hemodialysis session.
2. The control group will consume two portions of 120 ml at home on a specific schedule on a non-HD day.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

2231

Source(s) of Monetary Support

National Institute of Medical Science and Nutrition Salvador Zubirán, Abbott Laboratories (Mexico)

Ethics review

Status:
Approval date:
Contact:

Ethics and investigation committee from Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirán, 12/06/2017, ref: 2231

Results

• Results available: Yes
• Date Completed: 01/03/2019