The Effect of Food Intake During Hemodialysis on Blood Pressure

NCT ID: NCT05405348

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-03-30

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

The control group received routine care (T0)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

The patients did not eat anything during hemodialysis.

Interventions

Intervention

The patients did not eat anything during hemodialysis.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

melek avcı

OTHER

Sponsor Role: lead

Responsible Party

melek avcı

Department of Internal Medicine Nursing, MsC, RN

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Melek Avcı, PhD Student

Role: STUDY_DIRECTOR

Akdeniz University

Fatma Arikan, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2012-KAEK-20-547

Identifier Type: -

Identifier Source: org_study_id