NCT06586853

Brief Summary

Assessment of the major hemodialysis outcomes which are vascular access events, mortality and hospitalization Quality of life in end stage renal disease (ESRD) patients undergoing regular hemodialysis in upper Egypt and analysis of the major hemodialysis outcomes along a one year duration.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

August 24, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

August 24, 2024

Last Update Submit

September 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of the major hemodialysis outcomes

    Assessment of the major hemodialysis outcomes including change in serum creatinine in mg\\dl

    3 months

Study Arms (2)

Hemodialysis patients in Horus hospital

250 patients will be studied for complications and outcome of regular hemodialysis sessions in Horus hospital

Hemodialysis patients in Isis hospital

50 patients will be studied for complications and outcome of regular hemodialysis sessions in Isis hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic kidney disease on regular hemodialysis with age more than 18 years old in 2 dialysis centers in Upper Egypt

You may qualify if:

  • Aged ≥ 18 years old.
  • Patients receiving regular maintenance hemodialysis for at least three months
  • Patients receiving regular hemodialysis (three times a week for four hours each session).
  • Patients treated at an in-center hemodialysis

You may not qualify if:

  • Patients treated with a home-based hemodialysis .
  • Non end stage renal disease patients undergoing hemodialysis due to any other indication.
  • Refuse to share in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Zhao X, Niu Q, Gan L, Hou FF, Liang X, Ni Z, Chen Y, Zhao J, Bieber B, Robinson B, Chen X, Zuo L. Baseline data report of the China Dialysis Outcomes and Practice Patterns Study (DOPPS). Sci Rep. 2021 Jan 13;11(1):873. doi: 10.1038/s41598-020-79531-4.

    PMID: 33441625BACKGROUND
  • Matsuzawa R, Kamitani T, Roshanravan B, Fukuma S, Joki N, Fukagawa M. Decline in the Functional Status and Mortality in Patients on Hemodialysis: Results from the Japan Dialysis Outcome and Practice Patterns Study. J Ren Nutr. 2019 Nov;29(6):504-510. doi: 10.1053/j.jrn.2018.10.012. Epub 2018 Dec 24.

    PMID: 30591357BACKGROUND

Study Officials

  • Mohsen A Ramadan, Master

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Samir k Abdelhamid, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohsen A Ramadan, Master

CONTACT

Samir K Abdelhamid, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

August 24, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09