Recovery Time and Affecting Factors in Hemodialysis Patients

March 19, 2021 updated by: Nurten Ozen, Istanbul Demiroglu Bilim University

Do Biochemical Parameters and Intradialytic Symptoms Affect Post-dialysis Recovery Time?: A Cross-sectional Study

Patients undergoing hemodialysis (HD) can experience symptoms such as lassitude, pain, muscle cramps, nausea, vomiting, constipation, diarrhea, rash, skin dryness, sleep disorders, and emotional and sexual problems after the treatment. Many chronic HD patients do not feel well after the treatment sessions and need some time to recover. This recovery time is defined as the time required to recover from the feelings of lassitude and fatigue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The recovery time not only decreases the quality of life but also increases the risk of mortality and morbidity. As a prolonged recovery time affects both the patients and the healthcare professionals and caregivers, there has been increased interest on determining the modifiable treatment-related factors in the international literature. The patients are limited in their daily living activities at home and at work during this period and a significant amount of time is therefore required to go back to normal life.

Study Type

Observational

Enrollment (Actual)

86

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, 34384
        • Demiroglu Bilim University
    • Sisli
      • Istanbul, Sisli, Turkey, 34360
        • Demiroglu Bilim University

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Being on HD for 4 hours a day on 3 days per week for at least 6 months and 18 years or older

Description

Inclusion Criteria:

  • 18 years or older
  • Being on HD for 4 hours a day on 3 days per week for at least 6 months
  • No communication problem
  • Volunteering to participate to the study

Exclusion Criteria:

  • Younger than 18 years
  • Shorter being on HD for 4 hours a day on 3 days per week for at least 6 months
  • Have communication problem
  • Not volunteering to participate to the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-dialysis Recovery Time
Time Frame: Up to 7 days
Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.
Up to 7 days
Number of Participants With Intradialytic Hypotension
Time Frame: Up to 7 days
It is defined in the European Best Practice Guideline (EBPG) as a decrease of 20 mmHg or more in the systolic blood pressure or 10 mmHg or more in the mean arterial blood pressure together with symptoms requiring nursing intervention.
Up to 7 days
Rate of Dialysis Symptoms
Time Frame: Up to 7 days
It was identified with Dialysis Symptom Index (DSI). DSI consists of 30 items. We queried the subjects regarding symptoms in the last 7 days. The effect was evaluated with a Likert type scale from 0 to 4, representing "not at all" to "significantly". The total score of the DSI ranges from 0 to 150. A score of zero reflects no symptoms while increasing total scores reflect increasing effects of the symptoms.
Up to 7 days

Collaborators and Investigators

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

Sponsor

Istanbul Demiroglu Bilim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2019

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

February 15, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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