- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07821788
Twice vs Thrice Weekly Hemodialysis: Clinical Outcomes and Quality of Life
Clinical Outcomes and Health-Related Quality of Life in Patients Receiving Twice- Versus Thrice-Weekly Maintenance Hemodialysis: A Prospective Comparative Study
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Thrice-weekly maintenance hemodialysis is the conventional schedule. Twice-weekly hemodialysis is used selectively in patients with residual kidney function. Local prospective comparative data in Egypt are limited.
This observational study will include adults with end-stage kidney disease receiving established twice-weekly or thrice-weekly in-center maintenance hemodialysis. Patients will be followed according to their prescribed schedule without research-driven changes. Health-related quality of life will be assessed using the Arabic KDQOL-36 at baseline, 3 months, and 6 months. Clinical outcomes including adequacy, residual kidney function, hospitalization, and mortality will be recorded.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Justin g shawky, Resident
- Telefonnummer: 01281006606
- E-mail: Justen.18313387@med.aun.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- - Age 18 years or older
- Established end-stage kidney disease requiring maintenance hemodialysis
- Receiving in-center maintenance hemodialysis at Assiut University Hospitals
- On maintenance hemodialysis for at least one month before enrollment
- Established twice-weekly or thrice-weekly schedule prescribed by the treating team
- Clinically stable at recruitment
- Able to understand and respond to the questionnaire
- Written informed consent
Exclusion Criteria:
- - Acute kidney injury without established end-stage kidney disease
- Hemodialysis for less than one month
- Peritoneal dialysis or kidney transplantation during follow-up
- Acute severe illness requiring intensive care at recruitment
- Severe cognitive, psychiatric or neurological impairment preventing reliable questionnaire responses
- Active malignancy with expected survival too short to complete follow-up
- Temporary dialysis solely for an acute indication
- Refusal to participate
- Permanent transfer to another dialysis center during follow-up
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Twice-weekly hemodialysis
Adults receiving established twice-weekly maintenance hemodialysis.
|
|
Thrice-weekly hemodialysis
Adults receiving established thrice-weekly maintenance hemodialysis.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health-related quality of life score
Tidsramme: At baseline, 3 months, and 6 months
|
Mean total score of the Arabic Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire.
The KDQOL-36 score ranges from 0 to 100; higher scores indicate better health-related quality of life.
|
At baseline, 3 months, and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dialysis adequacy
Tidsramme: Up to 6 months
|
Mean single-pool Kt/V (for thrice-weekly) or weekly Kt/V incorporating residual kidney clearance (for twice-weekly).
|
Up to 6 months
|
|
Residual urine output
Tidsramme: Up to 6 months
|
Mean daily urine volume (mL/day) in patients with residual kidney function.
|
Up to 6 months
|
|
Hospitalization rate
Tidsramme: Up to 6 months
|
Proportion of patients requiring hospital admission during follow-up.
|
Up to 6 months
|
|
Interdialytic weight gain
Tidsramme: Up to 6 months
|
Mean interdialytic weight gain (kg).
|
Up to 6 months
|
|
Mortality
Tidsramme: Up to 6 months
|
Proportion of patients who die during the follow-up period.
|
Up to 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: marwa k abdo, prof, Internal Medicine Department, Assiut University Hospitals
Publikationer og nyttige links
Generelle publikationer
- Ackerman SD, Monk KR. The scales and tales of myelination: using zebrafish and mouse to study myelinating glia. Brain Res. 2016 Jun 15;1641(Pt A):79-91. doi: 10.1016/j.brainres.2015.10.011. Epub 2015 Oct 20.
- Hastaoglu F, Mollaoglu M. The effects of activities of daily living education on the independence and life satisfaction of elders. Perspect Psychiatr Care. 2022 Oct;58(4):2978-2985. doi: 10.1111/ppc.13149. Epub 2022 Aug 27.
- He XK, Su TT, Si JM, Sun LM. Metformin Is Associated With Slightly Reduced Risk of Colorectal Cancer and Moderate Survival Benefits in Diabetes Mellitus: A Meta-Analysis. Medicine (Baltimore). 2016 Feb;95(7):e2749. doi: 10.1097/MD.0000000000002749.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Nyreinsufficiens
- Nyreinsufficiens, kronisk
- Patologiske tilstande, tegn og symptomer
- Nyresvigt, kronisk
Andre undersøgelses-id-numre
- HD-Frequency-QoL-Assiut-2026
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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