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Completed

NCT Number: NCT04727281

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation Score

Other

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 .

Primary outcomes

  1. dialysis recovery time

    Time frame: 48-72 hours

    The time needed for the patient to recover from a dialysis session (in minutes).

Secondary outcomes

  1. quality of life assessment

    Time frame: 90 days

    Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form.

  2. nutritional status

    Time frame: 90 days

    Data about nutritional status using the Malnutrition-Inflammation Score

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2021
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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