End Stage Renal Disease PatientsNCT03779750
Causes Of End Stage Renal Disease In Patients Undergoing Regular Hemodialysis
An observational study of End Stage Renal Disease Patients, run by Assiut University at 2 sites in Egypt.
Trial summary
CKD is defined as kidney damage for ≥3 months, as defined by structural and or functional abnormalities of the kidney, with or without decreased GFR or GFR <60 mL/min/1.73m2 for ≥3 months, with or without kidney damage. CKD is classified based on cause, GFR category, and albuminuria category (CGA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease Patients
- What is being tested?
- s.creatinine
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2021
- 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
- Adult, Older adult
Study population: All ESRD patients on regular hemodialysis in dialysis unit of Assiut university Hospital duing one year.
Who may be able to join
- All ESRD patients >18years old in Assuit University Hospital dialysis unit .
- Patients on regular haemodialysis for more than six months.
Who cannot join
- ESRD patients<18years old .
- patients with acute kidney injury .
- patients on haemodialysis for less than six months.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut University Hospital
Asyut, Assiut University71515
Hudna A Ahmed, Residant, 00201096365187, hudna.abdullah@yahoo.com
Essam M Abdel Aziz, Doctor, 00201009699081, essam.nephro@gmail.com
Hudna Abdullah Ahmed
Asyut
About this study
Official title: CausesOf End Stage Renal Disease In Patients Undergoing Regular Hemodialysis In Assiut University Hospital
CKD is defined as kidney damage for ≥3 months, as defined by structural and or functional abnormalities of the kidney, with or without decreased GFR or GFR <60 mL/min/1.73m2 for ≥3 months, with or without kidney damage. CKD is classified based on cause, GFR category, and albuminuria category (CGA). ESRD has become a public health problem worldwide, with recent reports showing that the total number of ESRD patients has been growing dramatically.
Read the detailed description
The prevalence ESRD undergoing maintenance dialysis in 2010 was 284 individuals per million population (pmp) worldwide, which has increased 1.7 times from 165 pmp patients in 1990.
In Egypt, the prevalence of dialysis patients has increased from 225 pmp in 1996 to 483 pmp in 2008(according to last Egyptian renal registry) and the main causes of ESKD in Egypt, other than diabetic nephropathy, included hypertensive kidney disease, chronic glomerulonephritis, unknown etiology, chronic pyelonephritis, schistosomal obstructive uropathy, and schistosomal nephropathy .
It is well established that diabetic kidney disease is the most common cause or in combination with hypertensive nephropathy are the most common causes of end-stage renal disease (ESRD) in developed and developing countries. Patient survival in diabetics on maintenance renal replacement therapy including hemodialysis (HD), peritoneal dialysis (PD) and kidney transplantation is significantly lower than that seen in nondiabetics with ESRD. The poor prognosis of diabetic patients with ESRD is partly due to presence of significant cardiovascular disease, problems with vascular access, more susceptible to infections, foot ulcer, and hemodynamic instability during HD.
Hemodialysis (HD) is the first line of renal replacement therapy in the investigator's country. It is well known that patients on RRT are of greater risk for complications and worse prognosis in comparison to patients with the same co-morbidities but not on RRT.
The most common complicatons of hemodialysis are hypotensive episodes, muscular cramps, itching, arrhythmias,and anaphylactic responses during the sessions.
- Conditions
- End Stage Renal Disease Patients
- Being tested
- s.creatinine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
s.creatinineDiagnostic test
Also called blood urea
All ESRD patients on regular hemodialysis in dialysis unit of Assiut university Hospital duing one year. will be subjected to 3- Routine investigations including complete blood picture ,blood urea , s.creatinine,urine analysis , calcium, phosphorus, and parathyroid hormone.
| Study group | Role | What they receive |
|---|---|---|
| End Stage Renal Disease Patients | complete blood picture blood urea s.creatinine urine analysis calcium phosphorus parathyroid hormone. 4- Hepatitis BsAg,HCV-Abs and HIV. Receives: Diagnostic Test: s.creatinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find out the possible etiologies of ESRD in patients undergoing regular hemodialysis in Assiut university hospital.
- prevalence of ESRD on regular hemodialysis(in percentage )among different age groups ( measured by years)
- frequencies(in percentage)of different etiologies in ESRD on regular hemodialysis.
Measured: Within one year
To do registration for ESRD patients undergoing regular haemodialysis in assuit university hospital dialysis unit
- Relation between different causes of ESRD and life expectance.
Measured: Within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease PatientsStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hudna abdullah, Assiut University
- Investigators
- Mostafa A Haridy, Prof.Dr, Principal investigator, Unaffiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779750
- Sponsor's protocol ID
- COESRDIPURHIAUH
- Status last verified
- Dec 2018
- First submitted
- 20 May 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Solomon R. PRESERVE: The End or the Beginning of a New Era in Prevention of Contrast-Associated Acute Kidney Injury? Am J Kidney Dis. 2018 Sep;72(3):322-324. doi: 10.1053/j.ajkd.2018.03.013. Epub 2018 May 8. No abstract available.
PubMed 29751980Thomas B, Wulf S, Bikbov B, Perico N, Cortinovis M, Courville de Vaccaro K, Flaxman A, Peterson H, Delossantos A, Haring D, Mehrotra R, Himmelfarb J, Remuzzi G, Murray C, Naghavi M. Maintenance Dialysis throughout the World in Years 1990 and 2010. J Am Soc Nephrol. 2015 Nov;26(11):2621-33. doi: 10.1681/ASN.2014101017. Epub 2015 Jul 24.
PubMed 26209712Ghaderian SB, Hayati F, Shayanpour S, Beladi Mousavi SS. Diabetes and end-stage renal disease; a review article on new concepts. J Renal Inj Prev. 2015 Jun 1;4(2):28-33. doi: 10.12861/jrip.2015.07. eCollection 2015.
PubMed 26060834Ikizler TA, Schulman G. Hemodialysis: techniques and prescription. Am J Kidney Dis. 2005 Nov;46(5):976-81. doi: 10.1053/j.ajkd.2005.07.037. No abstract available.
PubMed 16253743
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CausesOf End Stage Renal Disease In Patients Undergoing Regular Hemodialysis In Assiut University Hospital
- ClinicalTrials.gov ID
- NCT03779750
- Acronym / sponsor ID
- COESRDIPURHIAUH
- Conditions
- End Stage Renal Disease Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 19 Dec 2018 (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.
CKD is defined as kidney damage for ≥3 months, as defined by structural and or functional abnormalities of the kidney, with or without decreased GFR or GFR <60 mL/min/1.73m2 for ≥3 months, with or without kidney damage. CKD is classified based on cause, GFR category, and albuminuria category (CGA). ESRD has become a public health problem worldwide, with recent reports showing that the total number of ESRD patients has been growing dramatically.
Detailed description
The prevalence ESRD undergoing maintenance dialysis in 2010 was 284 individuals per million population (pmp) worldwide, which has increased 1.7 times from 165 pmp patients in 1990.
In Egypt, the prevalence of dialysis patients has increased from 225 pmp in 1996 to 483 pmp in 2008(according to last Egyptian renal registry) and the main causes of ESKD in Egypt, other than diabetic nephropathy, included hypertensive kidney disease, chronic glomerulonephritis, unknown etiology, chronic pyelonephritis, schistosomal obstructive uropathy, and schistosomal nephropathy .
It is well established that diabetic kidney disease is the most common cause or in combination with hypertensive nephropathy are the most common causes of end-stage renal disease (ESRD) in developed and developing countries. Patient survival in diabetics on maintenance renal replacement therapy including hemodialysis (HD), peritoneal dialysis (PD) and kidney transplantation is significantly lower than that seen in nondiabetics with ESRD. The poor prognosis of diabetic patients with ESRD is partly due to presence of significant cardiovascular disease, problems with vascular access, more susceptible to infections, foot ulcer, and hemodynamic instability during HD.
Hemodialysis (HD) is the first line of renal replacement therapy in the investigator's country. It is well known that patients on RRT are of greater risk for complications and worse prognosis in comparison to patients with the same co-morbidities but not on RRT.
The most common complicatons of hemodialysis are hypotensive episodes, muscular cramps, itching, arrhythmias,and anaphylactic responses during the sessions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End Stage Renal Disease Patients | – | Diagnostic Test: s.creatininecomplete blood picture blood urea s.creatinine urine analysis calcium phosphorus parathyroid hormone. 4- Hepatitis BsAg,HCV-Abs and HIV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All ESRD patients on regular hemodialysis in dialysis unit of Assiut university Hospital duing one year.
Key inclusion criteria (2 listed)
- All ESRD patients >18years old in Assuit University Hospital dialysis unit .
- Patients on regular haemodialysis for more than six months.
Key exclusion criteria (3 listed)
- ESRD patients<18years old .
- patients with acute kidney injury .
- patients on haemodialysis for less than six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| s.creatinineAlso: blood ureaAll ESRD patients on regular hemodialysis in dialysis unit of Assiut university Hospital duing one year. will be subjected to 3- Routine investigations including complete blood picture ,blood urea , s.creatinine,urine analysis , calcium, phosphorus, and parathyroid hormone. | Diagnostic test | End Stage Renal Disease Patients |
Primary outcome
To find out the possible etiologies of ESRD in patients undergoing regular hemodialysis in Assiut university hospital.
Time frame: Within one year
* prevalence of ESRD on regular hemodialysis(in percentage )among different age groups ( measured by years) * frequencies(in percentage)of different etiologies in ESRD on regular hemodialysis.
To do registration for ESRD patients undergoing regular haemodialysis in assuit university hospital dialysis unit
Time frame: Within one year
• Relation between different causes of ESRD and life expectance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 29751980Solomon R. PRESERVE: The End or the Beginning of a New Era in Prevention of Contrast-Associated Acute Kidney Injury? Am J Kidney Dis. 2018 Sep;72(3):322-324. doi: 10.1053/j.ajkd.2018.03.013. Epub 2018 May 8. No abstract available.
- Background: PubMed 26209712Thomas B, Wulf S, Bikbov B, Perico N, Cortinovis M, Courville de Vaccaro K, Flaxman A, Peterson H, Delossantos A, Haring D, Mehrotra R, Himmelfarb J, Remuzzi G, Murray C, Naghavi M. Maintenance Dialysis throughout the World in Years 1990 and 2010. J Am Soc Nephrol. 2015 Nov;26(11):2621-33. doi: 10.1681/ASN.2014101017. Epub 2015 Jul 24.
- Background: PubMed 26060834Ghaderian SB, Hayati F, Shayanpour S, Beladi Mousavi SS. Diabetes and end-stage renal disease; a review article on new concepts. J Renal Inj Prev. 2015 Jun 1;4(2):28-33. doi: 10.12861/jrip.2015.07. eCollection 2015.
- Background: PubMed 16253743Ikizler TA, Schulman G. Hemodialysis: techniques and prescription. Am J Kidney Dis. 2005 Nov;46(5):976-81. doi: 10.1053/j.ajkd.2005.07.037. No abstract available.
- 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.
Mostafa A Haridy, Prof.Dr principal investigator
Unaffiliation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease Patients, run by Assiut University at 2 sites in Egypt.
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 2 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hudna A Ahmed, resident (00201096365187, hudna.abdullah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find out the possible etiologies of ESRD in patients undergoing regular hemodialysis in Assiut university hospital. (time frame: Within one year). The study lists 2 primary outcomes in all. 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 NCT03779750, which also lists 4 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 Dec 2018.