Hemodialysis ComplicationNCT06586853
Outcome and Complications of Regular Hemodialysis
An observational study of Hemodialysis Complication, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease on regular hemodialysis with age more than 18 years old in 2 dialysis centers in Upper Egypt
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Complications and Outcome of Regular Hemodialysis Patients in Upper Egypt: Two Center Prospective Study
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.
Read the 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.
- Conditions
- Hemodialysis Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the major hemodialysis outcomes
Assessment of the major hemodialysis outcomes including change in serum creatinine in mg\dl
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Abouelhassan Ramadan Sedik, Assiut University
- Investigators
- Mohsen A Ramadan, Master, Principal investigator, Assiut UniversitySamir k Abdelhamid, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586853
- Sponsor's protocol ID
- Outcome of Hemodialysis
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33441625Matsuzawa 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.
PubMed 30591357
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Complications and Outcome of Regular Hemodialysis Patients in Upper Egypt: Two Center Prospective Study
- ClinicalTrials.gov ID
- NCT06586853
- Acronym / sponsor ID
- Outcome of Hemodialysis
- Conditions
- Hemodialysis Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease on regular hemodialysis with age more than 18 years old in 2 dialysis centers in Upper Egypt
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the major hemodialysis outcomes
Time frame: 3 months
Assessment of the major hemodialysis outcomes including change in serum creatinine in mg\dl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 33441625Zhao 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.
- Background: PubMed 30591357Matsuzawa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen A Ramadan, Master principal investigator
Assiut University
Samir k Abdelhamid, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Complication, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohsen A Ramadan, Master (00201005880429, mohsen.aqleeaat.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the major hemodialysis outcomes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06586853, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.