Renal DialysisNCT05405348
The Effect of Food Intake During Hemodialysis on Blood Pressure
A study testing Intervention in people with Renal Dialysis, run by melek avcı at 1 site in Turkey (Türkiye).
Trial summary
Intradialytic hypotension is one of the most common complications associated with food intake during hemodialysis. Whether patients should be allowed to eat during hemodialysis is still a moot point. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Mar 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being over the age of 18
- Having CKD and being in the hemodialysis program
- Having the ability to understand and speak
- Being on HD treatment for 6 months or longer
- Weight gain of 4 kg or less between two HD sessions
- Standard HD is applied 3 days a week for 4 hours
Who cannot join
- The patient's communication difficulties, speech and understanding deterioration,
- Being on dialysis for less than 6 months,
- Interdialytic weight gain of more than 4kg,
- The patient is not suitable for blood pressure measurement from the arm,
- The patient used antihypertensive before HD,
- Entering HD less than or more than 3 days a week,
- More or less than 4 hours of HD input.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Food Intake During Hemodialysis on Blood Pressure: A Non-randomized Experimental Trial
Intradialytic hypotension is one of the most common complications associated with food intake during hemodialysis. Whether patients should be allowed to eat during hemodialysis is still a moot point.
This nonrandomized experimental trial investigated the effect of food intake during hemodialysis on blood pressure of patients. The sample consisted of 54 chronic patients receiving hemodialysis treatment. Researchers monitored the patients in two hemodialysis sessions; first meeting (T0) and second meeting (T1) which is one week later from T0. In the first meeting which is ''hemodialysis in fed state'', they ate the standard food served by the clinic at regular hours which means routine care of hemodialysis clinic. In the second meeting which is ''hemodilaysis in fasting state'', they did not eat anything during hemodialysis which means intervention part of the study. Both hemodyalisis in fed and fasting state, researchers recorded patient's blood pressure were monitozied in the mid-hemodiyalsis sessions. Patient' s sociodemographic and disease characteristics were recorded. Patient' s blood pressure monitorized by the ambulatory blood pressure monitor.
Read the detailed description
Researchers monitored the patients in two hemodialysis sessions; first meeting (T0) and second meeting (T1) which is one week later from T0. In the first meeting which is ''hemodialysis in fed state'', they ate the standard food (in clinic routine) served by the clinic at regular hours which means routine care of hemodialysis clinic. In the second meeting patients did not eat anything during hemodialysis which means intervention part of the study. Both hemodyalisis in fed and fasting state, researchers recorded patient's blood pressure were monitozied in the mid-hemodiyalsis sessions. Patient' s sociodemographic and disease characteristics were recorded. Patient' s blood pressure monitorized by the ambulatory blood pressure monitor.
Blood pressure measurements were made using Suntech Bravo Ambulatory Blood Pressure Monitoring (Morrisville, USA). Blood pressure was evaluated in the supine position with the use of a brachial cuff. The blood pressure measurement was made in the midweek dialysis session on the day of the measurement. Before the patient entered hemodialysis, an ambulatory blood pressure monitor was placed and blood pressure was measured at 15-minute intervals throughout the 4-hour hemodialysis session. A total of 16 measurements were made. The patients did not consume any food during the 4-hour dialysis session.
- Conditions
- Renal Dialysis
- Being tested
- Intervention
- Keywords
- hemodialysis, blood pressure, intradialytic food intake, intradialytic hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The patients did not eat anything during hemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group received routine care (T0) |
| Intervention | Experimental | Same patients, one week after T0, T1 was applied in middialysis. In T1, patients did not consume food at least half an hour before coming to hemodialysis. They also did not consume any food during hemodialysis. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of food consumption on intradialytic blood pressure
Blood pressure measurements were made using Suntech Bravo Ambulatory Blood Pressure Monitoring (Morrisville, USA). Blood pressure was evaluated in the supine position with the use of a brachial cuff. The blood pressure measurement was made in the midweek dialysis session on the day of the measurement. Before the patient entered hemodialysis, an ambulatory blood pressure monitor was placed and blood pressure was measured at 15-minute intervals throughout the 4-hour hemodialysis session. A total of 16 measurements were made.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jan 2019
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- In this study, one group patients were observed two different times. First meeting(T0, patients took routine care which include fed state during the hemodialisis.Second meeting (T1) patients took intervention which include fasting state during the hemodialisis.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- melek avcı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, melek avcı, Akdeniz University
- Investigators
- Melek Avcı, PhD Student, Study director, Akdeniz UniversityFatma Arikan, PhD, RN, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405348
- Sponsor's protocol ID
- 2012-KAEK-20-547
- Status last verified
- Jun 2022
- First submitted
- 23 Mar 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food Intake During Hemodialysis on Blood Pressure: A Non-randomized Experimental Trial
- ClinicalTrials.gov ID
- NCT05405348
- Acronym / sponsor ID
- 2012-KAEK-20-547
- Conditions
- Renal Dialysis
- Keywords
- hemodialysis, blood pressure, intradialytic food intake, intradialytic hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- melek avcıUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 6 Jun 2022 (actual)
- 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.
Intradialytic hypotension is one of the most common complications associated with food intake during hemodialysis. Whether patients should be allowed to eat during hemodialysis is still a moot point.
This nonrandomized experimental trial investigated the effect of food intake during hemodialysis on blood pressure of patients. The sample consisted of 54 chronic patients receiving hemodialysis treatment. Researchers monitored the patients in two hemodialysis sessions; first meeting (T0) and second meeting (T1) which is one week later from T0. In the first meeting which is ''hemodialysis in fed state'', they ate the standard food served by the clinic at regular hours which means routine care of hemodialysis clinic. In the second meeting which is ''hemodilaysis in fasting state'', they did not eat anything during hemodialysis which means intervention part of the study. Both hemodyalisis in fed and fasting state, researchers recorded patient's blood pressure were monitozied in the mid-hemodiyalsis sessions. Patient' s sociodemographic and disease characteristics were recorded. Patient' s blood pressure monitorized by the ambulatory blood pressure monitor.
Detailed description
Researchers monitored the patients in two hemodialysis sessions; first meeting (T0) and second meeting (T1) which is one week later from T0. In the first meeting which is ''hemodialysis in fed state'', they ate the standard food (in clinic routine) served by the clinic at regular hours which means routine care of hemodialysis clinic. In the second meeting patients did not eat anything during hemodialysis which means intervention part of the study. Both hemodyalisis in fed and fasting state, researchers recorded patient's blood pressure were monitozied in the mid-hemodiyalsis sessions. Patient' s sociodemographic and disease characteristics were recorded. Patient' s blood pressure monitorized by the ambulatory blood pressure monitor.
Blood pressure measurements were made using Suntech Bravo Ambulatory Blood Pressure Monitoring (Morrisville, USA). Blood pressure was evaluated in the supine position with the use of a brachial cuff. The blood pressure measurement was made in the midweek dialysis session on the day of the measurement. Before the patient entered hemodialysis, an ambulatory blood pressure monitor was placed and blood pressure was measured at 15-minute intervals throughout the 4-hour hemodialysis session. A total of 16 measurements were made. The patients did not consume any food during the 4-hour dialysis session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, one group patients were observed two different times. First meeting(T0, patients took routine care which include fed state during the hemodialisis.Second meeting (T1) patients took intervention which include fasting state during the hemodialisis.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group received routine care (T0) |
| Intervention | Experimental | Behavioral: InterventionSame patients, one week after T0, T1 was applied in middialysis. In T1, patients did not consume food at least half an hour before coming to hemodialysis. They also did not consume any food during hemodialysis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Being over the age of 18
- Having CKD and being in the hemodialysis program
- Having the ability to understand and speak
- Being on HD treatment for 6 months or longer
- Weight gain of 4 kg or less between two HD sessions
Key exclusion criteria (7 listed)
- The patient's communication difficulties, speech and understanding deterioration,
- Being on dialysis for less than 6 months,
- Interdialytic weight gain of more than 4kg,
- The patient is not suitable for blood pressure measurement from the arm,
- The patient used antihypertensive before HD,
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 |
|---|---|---|
| InterventionThe patients did not eat anything during hemodialysis. | Behavioural | Intervention |
Primary outcome
Effect of food consumption on intradialytic blood pressure
Time frame: 3 month
Blood pressure measurements were made using Suntech Bravo Ambulatory Blood Pressure Monitoring (Morrisville, USA). Blood pressure was evaluated in the supine position with the use of a brachial cuff. The blood pressure measurement was made in the midweek dialysis session on the day of the measurement. Before the patient entered hemodialysis, an ambulatory blood pressure monitor was placed and blood pressure was measured at 15-minute intervals throughout the 4-hour hemodialysis session. A total of 16 measurements were made.
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 6 Jun 2022.
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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.
Melek Avcı, PhD Student study director
Akdeniz University
Fatma Arikan, PhD, RN principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Renal Dialysis, run by melek avcı at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 6 Jun 2022. 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 Turkey (Türkiye). 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?
Effect of food consumption on intradialytic blood pressure (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2022.