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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03779750
Other study ID # COESRDIPURHIAUH
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date March 1, 2021

Study information

Verified date December 2018
Source Assiut University
Contact Hudna A Ahmed, resident
Phone 00201096365187
Email hudna.abdullah@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). ESRD has become a public health problem worldwide, with recent reports showing that the total number of ESRD patients has been growing dramatically.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date March 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All ESRD patients >18years old in Assuit University Hospital dialysis unit .

- Patients on regular haemodialysis for more than six months.

Exclusion Criteria:

- ESRD patients<18years old .

- patients with acute kidney injury .

- patients on haemodialysis for less than six months.

Study Design


Intervention

Diagnostic Test:
s.creatinine
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.

Locations

Country Name City State
Egypt Assiut University Hospital Assiut
Egypt Hudna Abdullah Ahmed Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Ghaderian 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. Review. — View Citation

Ikizler TA, Schulman G. Hemodialysis: techniques and prescription. Am J Kidney Dis. 2005 Nov;46(5):976-81. Review. — View Citation

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. — View Citation

Thomas 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Within one year
Primary To do registration for ESRD patients undergoing regular haemodialysis in assuit university hospital dialysis unit • Relation between different causes of ESRD and life expectance. Within one year