Dialysis; ComplicationsNCT04727281
Dialysis Recovery Time: Associated Factors and Its Relation to Quality of Life
A study testing Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation Score in people with Dialysis; Complications, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aims to identify factors affecting dialysis recovery time and the relation between dialysis recovery time and quality of life in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis; Complications
- What is being tested?
- Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation Score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dialysis; Complications
- Being tested
- Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation Score
- Keywords
- dialysis, recovery time, fatigue, quality of life
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation ScoreOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| dialysis patients | Experimental | Patients included in the study will be recruited from the dialysis units in Alexandria University Hospitals. Receives: Other: Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
dialysis recovery time
The time needed for the patient to recover from a dialysis session (in minutes).
Measured: 48-72 hours
Secondary outcomes (2)
quality of life assessment
Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form.
Measured: 90 days
nutritional status
Data about nutritional status using the Malnutrition-Inflammation Score
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Feb 2021
- Primary completion15 Aug 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- montasser M zeid, MD, Principal investigator, Professor of Nephrology & Internal Medicine, Faculty of medicine, Alexandria Universitymohamed mamdouh el sayed, MD, Study chair, Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria Universityosama M Refai, MBBCh, Study chair, resident of Nephrology & Internal Medicine, Alexandria University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727281
- Sponsor's protocol ID
- Dialysis Recovery Time
- Status last verified
- Apr 2022
- First submitted
- 19 Jan 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lindsay RM, Heidenheim PA, Nesrallah G, Garg AX, Suri R; Daily Hemodialysis Study Group London Health Sciences Centre. Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change. Clin J Am Soc Nephrol. 2006 Sep;1(5):952-9. doi: 10.2215/CJN.00040106. Epub 2006 Jul 6.
PubMed 17699312Sakkas GK, Karatzaferi C. Hemodialysis fatigue: just "simple" fatigue or a syndrome on its own right? Front Physiol. 2012 Jul 31;3:306. doi: 10.3389/fphys.2012.00306. eCollection 2012. No abstract available.
PubMed 22934057Rayner HC, Zepel L, Fuller DS, Morgenstern H, Karaboyas A, Culleton BF, Mapes DL, Lopes AA, Gillespie BW, Hasegawa T, Saran R, Tentori F, Hecking M, Pisoni RL, Robinson BM. Recovery time, quality of life, and mortality in hemodialysis patients: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2014 Jul;64(1):86-94. doi: 10.1053/j.ajkd.2014.01.014. Epub 2014 Feb 14.
PubMed 24529994Cohen DE, Lee A, Sibbel S, Benner D, Brunelli SM, Tentori F. Use of the KDQOL-36 for assessment of health-related quality of life among dialysis patients in the United States. BMC Nephrol. 2019 Apr 1;20(1):112. doi: 10.1186/s12882-019-1295-0.
PubMed 30935377As'habi A, Tabibi H, Hedayati M, Mahdavi-Mazdeh M, Nozary-Heshmati B. Association of malnutrition-inflammation score, dialysis-malnutrition score and serum albumin with novel risk factors for cardiovascular diseases in hemodialysis patients. Ren Fail. 2015 Feb;37(1):113-6. doi: 10.3109/0886022X.2014.967615. Epub 2014 Oct 8.
PubMed 25296104Elsayed MM, Zeid MM, Hamza OMR, Elkholy NM. Dialysis recovery time: associated factors and its association with quality of life of hemodialysis patients. BMC Nephrol. 2022 Sep 1;23(1):298. doi: 10.1186/s12882-022-02926-0.
PubMed 36050656
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis Recovery Time: Associated Factors and Its Relation to Quality of Life in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT04727281
- Acronym / sponsor ID
- Dialysis Recovery Time
- Conditions
- Dialysis; Complications
- Keywords
- dialysis, recovery time, fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify factors affecting dialysis recovery time and the relation between dialysis recovery time and quality of life in hemodialysis patients.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dialysis patients | Experimental | Other: Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation ScorePatients included in the study will be recruited from the dialysis units in Alexandria University Hospitals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation ScoreData 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 . | Other | dialysis patients |
Primary outcome
dialysis recovery time
Time frame: 48-72 hours
The time needed for the patient to recover from a dialysis session (in minutes).
2 secondary outcomes
quality of life assessment
Time frame: 90 days
nutritional status
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 17699312Lindsay RM, Heidenheim PA, Nesrallah G, Garg AX, Suri R; Daily Hemodialysis Study Group London Health Sciences Centre. Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change. Clin J Am Soc Nephrol. 2006 Sep;1(5):952-9. doi: 10.2215/CJN.00040106. Epub 2006 Jul 6.
- Background: PubMed 22934057Sakkas GK, Karatzaferi C. Hemodialysis fatigue: just "simple" fatigue or a syndrome on its own right? Front Physiol. 2012 Jul 31;3:306. doi: 10.3389/fphys.2012.00306. eCollection 2012. No abstract available.
- Background: PubMed 24529994Rayner HC, Zepel L, Fuller DS, Morgenstern H, Karaboyas A, Culleton BF, Mapes DL, Lopes AA, Gillespie BW, Hasegawa T, Saran R, Tentori F, Hecking M, Pisoni RL, Robinson BM. Recovery time, quality of life, and mortality in hemodialysis patients: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2014 Jul;64(1):86-94. doi: 10.1053/j.ajkd.2014.01.014. Epub 2014 Feb 14.
- Background: PubMed 30935377Cohen DE, Lee A, Sibbel S, Benner D, Brunelli SM, Tentori F. Use of the KDQOL-36 for assessment of health-related quality of life among dialysis patients in the United States. BMC Nephrol. 2019 Apr 1;20(1):112. doi: 10.1186/s12882-019-1295-0.
- Background: PubMed 25296104As'habi A, Tabibi H, Hedayati M, Mahdavi-Mazdeh M, Nozary-Heshmati B. Association of malnutrition-inflammation score, dialysis-malnutrition score and serum albumin with novel risk factors for cardiovascular diseases in hemodialysis patients. Ren Fail. 2015 Feb;37(1):113-6. doi: 10.3109/0886022X.2014.967615. Epub 2014 Oct 8.
- Derived from this study: PubMed 36050656Elsayed MM, Zeid MM, Hamza OMR, Elkholy NM. Dialysis recovery time: associated factors and its association with quality of life of hemodialysis patients. BMC Nephrol. 2022 Sep 1;23(1):298. doi: 10.1186/s12882-022-02926-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
montasser M zeid, MD principal investigator
Professor of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University
mohamed mamdouh el sayed, MD study chair
Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University
osama M Refai, MBBCh study chair
resident of Nephrology & Internal Medicine, Alexandria University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation Score in people with Dialysis; Complications, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dialysis recovery time (time frame: 48-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04727281, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.