The Effect of Food Intake During Hemodialysis on Blood Pressure

NCT05405348 | Completed DMC

• 1 other identifier: 2012-KAEK-20-547
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Dialysis

Keywords

hemodialysis; blood pressure; intradialytic food intake; intradialytic hypotension

Outcome Measures

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.

  3 month

Study Arms (2)

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.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

The patients did not eat anything during hemodialysis.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• melek avcı: lead

Study Sites (1)

Akdeniz University

Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Melek Avcı, PhD Student

  Akdeniz University

  STUDY DIRECTOR

• Fatma Arikan, PhD, RN

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Internal Medicine Nursing, MsC, RN

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: June 6, 2022
• Study Start: January 1, 2019
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

TU (1)