The Effect of Fluid Training Given to Hemodialysis Patients on Interdialytic Fluid Intake and Blood Pressure

August 6, 2024 updated by: Ülkü YILMAZ, University of Beykent
The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate. Fluid Control Scale in Hemodialysis Patients (HHSÖ), Blood Pressure Control Form, Bioimpedance Analysis, Bioimpedance Analysis Compliance Form, Things to Consider Before Bioimpedance Analysis, and Nutrition Booklet for Dialysis Patients were used to collect the data. Parametric methods were used to analyze the data. Differences between the proportions of categorical variables in independent groups were analyzed with Chi-Square and Fisher's exact tests. The t-test was used to compare quantitative continuous data between two independent groups. A dependent group t-test was used to compare intra-group measurements.

After randomization of the experimental and control groups, both groups were measured with the BCM (Fresenius Medical Care Body Composition Monitor) device. The experimental group was given face-to-face fluid restriction training in line with the Nutrition Booklet for Dialysis Patients. At the end of the second month, BCM was measured again in both groups. During the follow-up of the experimental group, training was repeated according to the needs of the patients.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Ülkü Yılmaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Above 18 years old
  • volunteering
  • good communication
  • chronic kidney failure
  • no amputation
  • hemodialysis 3 days a week

Exclusion Criteria:

  • Heart battery
  • dialysis 2 days a week
  • more than 200ml of urine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group

The experimental group will be informed about the purpose and method of the research and will be informed in writing.

Informed consent was obtained. Patient Tracking Form, which is a data collection tool, The researcher filled out the Fluid Restriction Scale in Hemodialysis Patients through face-to-face interviews with the patients.

The results of the biochemical parameters requested by the physician were recorded. Later Patients will be given a 15-20 minute individual session on fluid restriction in chronic renal failure.

A training and education booklet was provided. At the end of the training, the Fluid Restriction Scale in Hemodialysis Patients was applied to the experimental group as a posttest.
Behavioral: education
Patient education will be provide
Other Names:
  • Patient education will be provide
No Intervention: Control group
As for the control group, Information was given about the purpose and method of the research, and a written Informed consent was obtained. Data collection tools: Patient Follow-up Form, Hemodialysis patients fluid restriction scale The researcher completed it during face-to-face interviews with the patients. At the end of the follow-up period, the hemodialysis patients completed the fluid restriction scale as a final test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complying with fluid restriction
Time Frame: 14 weeks,

Thanks to the training given, patients consume less fluid. posttests were performed usingthe fluid control scale on Hemdodialysis patients.

The lowest score from the scale is 24 and the highest score is 72. from scale As the score increases, patients' compliance with fluid control also increases.
14 weeks,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Beykent

Investigators

  • Principal Investigator: ülkü yılmaz, Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

April 28, 2023

Study Completion (Actual)

April 28, 2023

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 29 temmuz

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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