NCT04727281

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

January 19, 2021

Last Update Submit

April 13, 2022

Conditions

Keywords

dialysis, recovery time, fatigue, quality of life

Outcome Measures

Primary Outcomes (1)

  • dialysis recovery time

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

    48-72 hours

Secondary Outcomes (2)

  • quality of life assessment

    90 days

  • nutritional status

    90 days

Study Arms (1)

dialysis patients

EXPERIMENTAL

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

Interventions

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 .

dialysis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 17699312BACKGROUND
  • Sakkas 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.

    PMID: 22934057BACKGROUND
  • Rayner 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.

    PMID: 24529994BACKGROUND
  • Cohen 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.

    PMID: 30935377BACKGROUND
  • As'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.

    PMID: 25296104BACKGROUND
  • Elsayed 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.

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • montasser M zeid, MD

    Professor of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University

    PRINCIPAL INVESTIGATOR
  • mohamed mamdouh el sayed, MD

    Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University

    STUDY CHAIR
  • osama M Refai, MBBCh

    resident of Nephrology & Internal Medicine, Alexandria University Hospitals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor & lecturer

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 27, 2021

Study Start

February 1, 2021

Primary Completion

August 15, 2021

Study Completion

September 15, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations