Blood PressureNCT02371018
Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis
A study testing Nepro in people with Blood Pressure and Kidney Failure, Chronic, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of nutritional supplementation during hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover design. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Blood Pressure, Kidney Failure, Chronic, Dietary Modification
- What is being tested?
- Nepro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists
Who cannot join
- Milk or soy allergy, more than 4 hypotensive events requiring intervention in the last two weeks, hospitalized due to hypotension in the previous week
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effect of nutritional supplementation during hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover design.
Read the detailed description
The consumption of food or nutritional supplements during hemodialysis treatment has been shown to improve nutritional status, improve quality of life, and reduce mortality.
Despite these observations, allowing patients to eat food during hemodialysis treatment is sometimes restricted in the United States. The reasons for this restrictive policy are multi-factorial, but include concerns related to drops in blood pressure BP or a reduced efficiency of solute removal following eating during HD treatment. An alternative to eating solid food is to provide patients with liquid nutritional supplements. Clinics in the US are more likely to allow the consumption of liquid nutritional supplements, however, little is known about the effect that liquid supplements have on blood pressure or treatment efficiency. Therefore, the investigators plan to examine the effect of nutritional supplementation during hemodialysis treatment on hemodynamics and treatment efficiency in a crossover design.
- Being tested
- Nepro
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeproDietary supplement
Patients will be asked to consume a single 8 oz can of Nepro
| Study group | Role | What they receive |
|---|---|---|
| Standard Hemodialysis | No intervention | Participants will be monitored during their normal hemodialysis treatment with no intervention administered |
| Hemodialysis with Nutrition Supplement | Experimental | Participants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro. Receives: Dietary Supplement: Nepro |
| Nutrition Supplement | Experimental | Participants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment. Receives: Dietary Supplement: Nepro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in beat-to-beat systolic blood pressure
Beat-to-beat blood pressure will be monitored throughout the treatment by finger plethysmography
Measured: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
Secondary outcomes (2)
Gastrointestinal symptoms during treatment by a rating scale
A validated version of the Gastrointestinal Symptom Rating Scale will be administered
Measured: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
Treatment efficiency measured by urea removal
Kt/V as determined from blood urea pre- and post-hemodialysis
Measured: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth R Wilund, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371018
- Sponsor's protocol ID
- 14385
- Status last verified
- Sep 2017
- First submitted
- 5 Feb 2015
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
PubMed 32390133
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis
- ClinicalTrials.gov ID
- NCT02371018
- Acronym / sponsor ID
- 14385
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of nutritional supplementation during hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover design.
Detailed description
The consumption of food or nutritional supplements during hemodialysis treatment has been shown to improve nutritional status, improve quality of life, and reduce mortality.
Despite these observations, allowing patients to eat food during hemodialysis treatment is sometimes restricted in the United States. The reasons for this restrictive policy are multi-factorial, but include concerns related to drops in blood pressure BP or a reduced efficiency of solute removal following eating during HD treatment. An alternative to eating solid food is to provide patients with liquid nutritional supplements. Clinics in the US are more likely to allow the consumption of liquid nutritional supplements, however, little is known about the effect that liquid supplements have on blood pressure or treatment efficiency. Therefore, the investigators plan to examine the effect of nutritional supplementation during hemodialysis treatment on hemodynamics and treatment efficiency in a crossover design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Hemodialysis | No intervention | –Participants will be monitored during their normal hemodialysis treatment with no intervention administered |
| Hemodialysis with Nutrition Supplement | Experimental | Dietary Supplement: NeproParticipants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro. |
| Nutrition Supplement | Experimental | Dietary Supplement: NeproParticipants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists
Key exclusion criteria (1 listed)
- Milk or soy allergy, more than 4 hypotensive events requiring intervention in the last two weeks, hospitalized due to hypotension in the previous week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeproPatients will be asked to consume a single 8 oz can of Nepro | Dietary supplement | Hemodialysis with Nutrition Supplement, Nutrition Supplement |
Primary outcome
Changes in beat-to-beat systolic blood pressure
Time frame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
Beat-to-beat blood pressure will be monitored throughout the treatment by finger plethysmography
2 secondary outcomes
Gastrointestinal symptoms during treatment by a rating scale
Time frame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
Treatment efficiency measured by urea removal
Time frame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 32390133Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth R Wilund, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nepro in people with Blood Pressure and Kidney Failure, Chronic, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in beat-to-beat systolic blood pressure (time frame: Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.