Outcome and Complications of Regular Hemodialysis

NCT ID: NCT06586853

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Regular dialysis treatment has been available at a national level in Egypt for more than three decades. Hemodialysis is a vital and lifesaving procedure so that many organizations, including governmental and non-governmental bodies, adopt it. Hemodialysis service is usually provided by either non-profit- or profit-based bodies.

Dialysis therapy ameliorates many of the clinical manifestations of renal failure and postpones otherwise imminent death . Despite this undeniable success, hemodialysis patients have higher mortality and hospitalization rates and lower quality of life than the general population. Also, patients must contend with unique treatment complications, such as vascular access failure, at considerable expense and morbidity .

Effective hemodialysis requires repeated and reliable access to the bloodstream through a central venous catheter or a surgically created arteriovenous communication (an autologous fistula or a synthetic graft). However, vascular access thrombosis and infection occur frequently and are the leading cause of dialysis-related morbidity.

Mortality in hemodialysis patients: The greatest number of deaths were due to infections, followed by withdrawal from dialysis, cardiac, sudden death, vascular, and other.

Quality of life in hemodialysis patients is reduced in all the health domains of Hemodialysis patients. Older age, male gender, unemployment, and duration of dialysis adversely affected the QOL scores.

Hospitalization in hemodialysis: Patients with end-stage kidney disease (ESKD) have a greater risk of comorbidities, including diabetes and anemia, and have higher hospital admission rates than patients with other diseases. The cause of hospital admissions is associated with end-stage kidney disease (ESKD) prognosis.

Conditions

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Hemodialysis Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemodialysis patients in Horus hospital

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

No interventions assigned to this group

Hemodialysis patients in Isis hospital

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients treated with a home-based hemodialysis .
2. Non end stage renal disease patients undergoing hemodialysis due to any other indication.
3. Refuse to share in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohsen Abouelhassan Ramadan Sedik

Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohsen A Ramadan, Master

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Samir k Abdelhamid, professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Mohsen A Ramadan, Master

Role: CONTACT

00201005880429

Samir K Abdelhamid, professor

Role: CONTACT

00201062949199

References

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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.

Reference Type BACKGROUND
PMID: 33441625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30591357 (View on PubMed)

Other Identifiers

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Outcome of Hemodialysis

Identifier Type: -

Identifier Source: org_study_id

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