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Not yet recruiting NCT06586853

Outcome and Complications of Regular Hemodialysis

Observational Hemodialysis Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hemodialysis Complication. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Complications and Outcome of Regular Hemodialysis Patients in Upper Egypt: Two Center Prospective Study

Overview

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

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.

Primary outcome measures

  • Assessment of the major hemodialysis outcomes [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 33441625
  • 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 30591357

Identifiers

NCT: NCT06586853 · Outcome of Hemodialysis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗