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CompletedNCT05405348Updated Jun 6, 2022

The Effect of Food Intake During Hemodialysis on Blood Pressure

An interventional study of Intervention in Renal Dialysis, sponsored by melek avcı. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by melek avcı · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Jan 2019, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Renal Dialysis

Keywords

  • hemodialysis
  • blood pressure
  • intradialytic food intake
  • intradialytic hypotension
03

In context

Lead sponsor

This is the only study on the registry with melek avcı as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • No intervention
    Control

    The control group received routine care (T0)

  • Experimental
    Intervention

    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.

    Behavioral: Intervention

Interventions

  • BehavioralIntervention

    The patients did not eat anything during hemodialysis.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 month

07

Study locations

1 site
  • Akdeniz University
    Antalya, 07100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05405348
Lead sponsor
melek avcı
Responsible party
melek avcı (Department of Internal Medicine Nursing, MsC, RN, Akdeniz University) — Sponsor-investigator
First posted
Jun 6, 2022
Start date
Jan 1, 2019
Primary completion
Mar 30, 2019
Completion
Mar 30, 2019
Last update
Jun 6, 2022

Study contacts

Melek Avcı, PhD Student
study director · Akdeniz University
Fatma Arikan, PhD, RN
principal investigator · Akdeniz University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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