Dialysis Recovery Time: Associated Factors and Its Relation to Quality of Life

April 13, 2022 updated by: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

Dialysis Recovery Time: Associated Factors and Its Relation to Quality of Life in Hemodialysis Patients.

This study aims to identify factors affecting dialysis recovery time and the relation between dialysis recovery time and quality of life in hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dialysis is defined as the diffusion of molecules in solution across a semipermeable membrane along an electrochemical concentration gradient. The primary goal of hemodialysis (HD) is to restore the intracellular and extracellular fluid environment that is characteristic of normal kidney function. In addition to diffusion, solutes may pass through pores in the membrane by means of a convective process driven by hydrostatic or osmotic pressure gradients a process called ultrafiltration. During ultrafiltration, there is no change in solute concentrations; its primary purpose is the removal of excess total body water.

Fatigue is a well-known and frequent symptom in HD patients with a reported association with the decrease in health-related quality of life commonly found in this population. The prevalence of fatigue ranges from 60% to as high as 97% in patients on long-term renal replacement therapy. Despite this fact, health care providers are still unaware of both its presence and severity.

The clinical assessment of fatigue in dialysis patient can be somehow difficult for the treating physicians. Patients usually show diversity in their recovery from fatigue. However, early recognition is essential because a number of treatable causes can be easily identified.

Post-HD fatigue is a common incapacitating symptom affecting renal population. It is defined as a feeling of exhaustion that regularly follows each dialysis procedure. Uremia-related factors such as anemia, nutritional deficiency and enhanced inflammatory state could possibly lead to post-HD fatigue. In addition, the HD procedure itself including the efficiency of HD session, type of dialyzer and ultrafiltration rate are potential exacerbating factors for post-HD fatigue.

Several methods have been proposed as a way to assess post-HD fatigue with the "time to recover (minutes) from HD" being one of them. Lindsay et al. assisted patients' responses to the single open-ended question, "How long does it take you to recover from a dialysis session?".Lindsay et al. found that post hemodialysis recovery time is an important indicator for patients' quality of life.

Health-related quality of life (HRQOL) is a critically important outcome for patients with end-stage renal disease (ESRD). The National Quality Forum selected the Kidney Disease Quality of Life Short-Form survey (KDQOL™-36) as the tool of choice for assessing this outcome in adult patients with ESRD; assessment is required within 4 months of initiating dialysis, and annually thereafter. This 36-question survey instrument was published in 2000. The KDQOL™-36 contains 5 subscales: the Physical Component Summary(PCS), Mental Component Summary (MCS), Burden of Kidney Disease (BKD), Symptoms and Problems of Kidney Disease (SPKD), and Effects of Kidney Disease (EKD). The first 2 subscales are a general measure of HRQOL, whereas the last 3 assess issues specific to patients with ESRD or earlier stages of chronic kidney disease.(15) The Kidney Disease Quality of Life Short Form 36 (KDQOL-36) provides accurate estimate for fatigue severity and was previously used in HD population.

Although post-HD fatigue commonly exists in dialysis patients, it is usually underestimated by physicians. For this reason, appropriate and early identification of symptoms and associated factors might improve the patient's quality of life. Extending the research in this area will certainly be of great value to HD population.

Study Type

Interventional

Enrollment (Actual)

210

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

  • Egypt
      • Alexandria, Egypt
        • Faculty of medicine, Alexandria 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • End Stage renal disease patients who have been assigned to regular long-term hemodialysis and perform thrice weekly, four hours HD sessions for more than 90 days.
  • Patient's age of 18 years of more. They should be able to read and write, and in a complete mental health.

Exclusion Criteria:

  • Inability to answer the questionnaires because of hearing or reading problems, dementia, actual instability of clinical conditions requiring hospitalization, liver failure, and active cancer.
  • Patients who experience a decline in the level of consciousness during the HD session.

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dialysis patients
Patients included in the study will be recruited from the dialysis units in Alexandria University Hospitals.
Other: Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation Score

Data about nutritional status using the Malnutrition-Inflammation Score, and Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form. Dialysis related data, The time needed for the patient to recover from a dialysis session (in minutes), Detailed history taking, Thorough physical examination, Laboratory Investigations:

• Hemoglobin , Serum sodium and potassium , Serum creatinine and blood urea , Serum phosphorus, serum calcium , Serum PTH level , Serum albumin ,CRP ,Total iron-binding capacity .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dialysis recovery time
Time Frame: 48-72 hours
The time needed for the patient to recover from a dialysis session (in minutes).
48-72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life assessment
Time Frame: 90 days
Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form.
90 days
nutritional status
Time Frame: 90 days
Data about nutritional status using the Malnutrition-Inflammation Score
90 days

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Study Chair: osama M Refai, MBBCh, resident of Nephrology & Internal Medicine, Alexandria University Hospitals
  • Principal Investigator: montasser M zeid, MD, Professor of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University
  • Study Chair: mohamed mamdouh el sayed, MD, Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria 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)

February 1, 2021

Primary Completion (Actual)

August 15, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Dialysis Recovery Time

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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