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.: PACTR202001714181321 Date of Approval: 15/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrafiltration (UF) Effectiveness on intradialytic hypertension (IDH)
Official scientific title Ultrafiltration (UF) Effectiveness on intradialytic hypertension (IDH) in chronic hemodialysed patients in a nephrology unit in Dakar: UF-IDH clinical trial.
Brief summary describing the background and objectives of the trial Progressive ultrafiltration (UF) could improve IDH. The aim of this work was to evaluate the effectiveness of progressive UF in the management of IDH.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/09/2018
Actual trial start date 04/11/2019
Anticipated date of last follow up 17/11/2018
Actual Last follow-up date 11/01/2020
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrafiltration 8 weeks Patients in the ultrafiltration group underwent a very gradual decrease in baseline weight of 0.25 kg per session with a decreasing UF profile depending on hemodynamic tolerance. 12
Control Group control 8 weeks In control group, we haven't do some thing 12 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All chronic hemodialysed patients (for more than 3 months) in Aristide Le Dantec hemodialysis units, undergoing IDH, aged at least 18 years and consenting to the study were included. Missing 3 sessions out of the last 6 before randomization; a clinical volume overload; clinical dehydration; intolerance to UF; severe cardiovascular comorbidities (stroke, ischemic heart disease, severe lower limbs obliterating arteriopathy (LLOA) or left ventricular ejection fraction (LVEF) less than 50%); deciding to not participate in the study; chronic hypotension. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 10/07/2019 Cheikh Anta Diop University ethics committee
Ethics Committee Address
Street address City Postal code Country
Cheikh anta diop Street Dakar 5005 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Progressive UF was associated with a significant reduction in the prevalence of IDH in our patients at week 4. Week 4 and Week 8
Secondary Outcome ultrafiltration was not always well tolerated. week 4 and week 8
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aristide Le Dantec hospital Pasteur Street Dakar 3001 Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
Aristide Le Dantec Hospital Pasteur street Dakar 3001 Senegal
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nephrology department Pasteur street Dakar 3001 Senegal Hospital
COLLABORATORS
Name Street address City Postal code Country
Faye Moustapha Aristide Le Dantec hospital / Pasteur Street Dakar 3001 Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bacary Ba babacary13@gmail.com +221772596225 Pasteur street
City Postal code Country Position/Affiliation
Dakar Senegal Nephrology department
Role Name Email Phone Street address
Public Enquiries Moustapha Faye mfayeintaida@gmail.com +221772596225 Pasteur
City Postal code Country Position/Affiliation
Dakar Senegal Nephrology department
Role Name Email Phone Street address
Scientific Enquiries Elhadji Fary KA babacary13@gmail.com +221772596225 Pasteur
City Postal code Country Position/Affiliation
Dakar Senegal Nephrology department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes It is an information letter which we explains patients benefits, risks, duration of the trial. the manuscrit is available if you want Informed Consent Form it available actually Key access criteria are: -Patient consent -Investigator approval All types of analysis are possible if the access criteria are met The decision maker is the principal investigator who is an assistant professor to the Cheikh Anta Diop university of Dakar
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No publish 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