Condition category
Not Applicable
Date applied
11/07/2017
Date assigned
13/07/2017
Last edited
26/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Hemodialysis (HD) is a process of purifying the blood of a person whose kidneys are not working normally. HD causes an inflammatory effect which decreases the appetite, increases certain gastrointestinal (digestive system) symptoms and consequently the patients consume fewer nutrients, increasing the risk of developing protein energy wasting (reduced body protein and fat mass). This could be treated and even prevented with oral nutritional supplementation containing extra protein and calories. It’s been suggested that oral supplementation during HD treatment, called intradialytic oral nutrition supplementation (ION), can improve survival. Despite the proposed benefits, health personnel see ION as a risk factor for many adverse events such as intradialytic hypotension (low blood pressure) and other gastrointestinal and adverse events like nausea, vomiting, diarrhea and infections. The prevalence of these events has been little studied, and health personnel in HD units should not base their decision not to give ION based on this limited evidence. Therefore, the aim of this study is to determine the safety of ION over intradialytic hypotension and its effectiveness over some clinical nutritional markers in comparison with standard supplementation (at home).

Who can participate?
Patients aged 18 to 65 who are receiving chronic (long-term) HD treatment

What does the study involve?
Participants are randomly allocated to one of two group. Both groups consume a liquid supplement containing extra protein and calories. The intervention group consume the supplement at minutes 60-75 and 210-225 of a HD session. The control group consume two portions of the supplement at home on a specific schedule on a non-HD day. The incidence of intradialytic hypotension is assessed during HD sessions.

What are the possible benefits and risks of participating?
This study may increase the limited general knowledge of the safety and effectiveness of ION, and may increase health personnel's confidence for giving supplements during HD treatment and therefore prevent or treat protein energy wasting in HD patients. Possible benefits for participants include improvement in protein levels, sensation of general wellness, and improvements in appetite and calorie-protein intake. Risks for patients include nausea, vomiting, diarrhoea, aspiration and hypotension during HD treatment.

Where is the study run from?
National Institute of Medical Science and Nutrition Salvador Zubirán (Mexico)

When is the study starting and how long is it expected to run for?
September 2017 to February 2018

Who is funding the study?
National Institute of Medical Science and Nutrition Salvador Zubirán (Mexico)

Who is the main contact?
Dr María de los Ángeles Espinosa Cuevas
angespinosac@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr María de los Ángeles Espinosa Cuevas

ORCID ID

http://orcid.org/0000-0001-9153-5155

Contact details

Vasco de Quiroga 15
Tlalpan
14080 Ciudad de México
CDMX
Mexico City
14080
Mexico
+ 52 (55) 54870900 ext. 7876
angespinosac@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2231

Study information

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

Acronym

Study hypothesis

Patients undergoing hemodialysis (HD) are in risk for developing Protein Energy Wasting (PEW) which increases risk for morbidity and mortality. PEW has many components in which energy consumption is crucial. Intradialytic supplementation is an effective anabolic strategy for improving albumin, prealbulmin and protein homeostasis. Despite these effective outcomes, health personnel perceive intradialytic supplementation as a risk for intradialytic hypotension and other gastrointestinal complications.

Study hypotheses:
1. Muscular strength, energy consumption and phase angle will increase at least 10% of their basal value after 3 months of intervention with a specific renal supplement.
2. There won't be more than 10% on the increase of the presence of intradialytic hypotension after intervention.

Ethics approval

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

Study design

Randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Hemodialysis

Intervention

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.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/09/2017

Overall trial end date

01/03/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant 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

Recruitment start date

28/11/2017

Recruitment end date

30/12/2018

Locations

Countries of recruitment

Mexico

Trial participating centre

National Institute of Medical Science and Nutrition Salvador Zubirán
Vasco de Quiroga 15 Tlalpan 14080 Ciudad de México CDMX
Mexico City
14080
Mexico

Sponsor information

Organisation

National Institute of Medical Science and Nutrition Salvador Zubirán

Sponsor details

Vasco de Quiroga no. 15
Mexico City
14080
Mexico
+52 (55) 54870900 ext. 7876
sam_ra89@hotmail.com

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

National Institute of Medical Science and Nutrition Salvador Zubirán

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Abbott Laboratories (Mexico)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists don’t have an exact date for publishing the results but they want it to be within 6 months of the overall trial end date. Also, they want it to be presented on the next international congress of the international society of renal nutrition and metabolism (Genova, Italy) as an oral or poster presentation and published in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. María de los Ángeles Espinosa Cuevas (angespinosac@gmail.com).

Intention to publish date

01/08/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/01/2018: The recruitment dates have been updated from 01/09/2017-31/12/2017 to 28/11/2017-30/12/2018. The target number of enrollments have been updated from 100 (50 in each arm) to 70. The overall trial end date has been updated from 01/02/2018 to 01/03/2019.