The Effect of Food Intake During Hemodialysis on Blood Pressure

Sponsor

melek avcı (Other)

Overall Status

Completed

CT.gov ID

NCT05405348

Collaborator

(none)

Enrollment

Location

Arms

2.9

Actual Duration (Months)

18.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis	Behavioral: Intervention	N/A

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

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Food Intake During Hemodialysis on Blood Pressure: A Non-randomized Experimental Trial

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Mar 30, 2019

Actual Study Completion Date :

Mar 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 The patients did not eat anything during hemodialysis.

Arm

Intervention/Treatment

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

The patients did not eat anything during hemodialysis.

Outcome Measures

Primary Outcome Measures

Effect of food consumption on intradialytic blood pressure [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akdeniz University	Antalya		Turkey	07100

Sponsors and Collaborators

melek avcı

Investigators

Study Director: Melek Avcı, PhD Student, Akdeniz University
Principal Investigator: Fatma Arikan, PhD, RN, Akdeniz University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

melek avcı, Department of Internal Medicine Nursing, MsC, RN, Akdeniz University

ClinicalTrials.gov Identifier:

NCT05405348

Other Study ID Numbers:

2012-KAEK-20-547

First Posted:

Jun 6, 2022

Last Update Posted:

Jun 6, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by melek avcı, Department of Internal Medicine Nursing, MsC, RN, Akdeniz University

hemodialysis

blood pressure

intradialytic food intake

intradialytic hypotension

Study Results

No Results Posted as of Jun 6, 2022