Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103564538911 Date of Approval: 26/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between incremental hemodialysis and conventional hemodialysis
Official scientific title Outcome of incremental hemodialysis in hemodialysis versus conventional hemodialysis
Brief summary describing the background and objectives of the trial The rule of residual kidney function in determination of dialysis dose in Chronic Kidney Disease patients stage five either incremental hemodialysis once or twice per week or conventional hemodialysis. Full dose dialysis in the form of 3 sessions per week each session is 4 hours.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) CKD
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/10/2020
Actual trial start date 13/10/2020
Anticipated date of last follow up 16/01/2021
Actual Last follow-up date 01/02/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 96
Recruitment status Closed to recruitment,follow-up continuing
Publication URL WWW.aun.edu.eg
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group incremental hemodialysis patients versus conventional hemodialysis 100 patients who diagnosed CKD stage 5 and start renal replacement therapy divided into 2 groups first group start incremental hemodialysis second group is conventional one 3 months full history intake full examination blood test radiological image asses dialysis adequacy kt\v 50 Uncontrolled
Experimental Group Determination of dialysis dose according to residual kidney function hemodialysis not full dose session till August 2021 describe outcome difference between incremental hemodialysis and conventional hemodialy and assess out come of incremental hemodialysis versus concentional hemodialysis as regard cinical ,labrotory and life style of patients in the form of asses control of blood pressure ,assess weight symptomof anemia and malnutrition and also asses complete biood count,calcium and phosphrus and parathyroid hormone 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 20 to 80 both sex urine output more than 1 litre per day age less than 20 and more than 80 pregnant females urine output less than 1 litre per day 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2020 Asuit university
Ethics Committee Address
Street address City Postal code Country
Algamea street Assuit 71511 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/03/2021 Assuit Faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Algamaaea street -Assuit city- Egypt Assuit 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome improve life style of ckd patients on hemodialysis treatment january 2021
Primary Outcome measure outcome of incremental hemodialysis versus conventional type and rule of residual kidney function in determining dialysis dose january 2021
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assuit university hospital Algamaea street-Assuit -Egypt Assuit 71511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eman Zaki Sohag -Taefik Alhakeem street Sohag 82749 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Assuit university ALgamea street Assuit 71511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa zaki Mostafa_mahmoud@yahoo.com 0020932715389 Alshoona street
City Postal code Country Position/Affiliation
Sohag 82749 Egypt sohag university
Role Name Email Phone Street address
Public Enquiries Manal Ezaldeen manal_ezaldeen@yahoo.com 0020246599 Kareem street
City Postal code Country Position/Affiliation
Assuit 71511 Egypt Assuit university hospital
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Tarek Mahmoudgak54@gmail.com 0020100764321 Thakafa street
City Postal code Country Position/Affiliation
Sohag 82749 Egypt Assuit university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 100 patients who start hemodialysis 50 of them will take incremental hemodialysis session and the rest wiill attend to conventional hemodialysis session Study Protocol january 2021 incremental hemodialysis - conventional hemodialysis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.aun.edu.eg No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information