| CTRI Number |
CTRI/2022/03/041227 [Registered on: 21/03/2022] Trial Registered Prospectively |
| Last Modified On: |
17/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the role of doppler ultrasonography for arteriovenous fistula surveillance in maintenance hemodialysis patients |
|
Scientific Title of Study
|
Role of doppler ultrasonography for arteriovenous fistula surveillance in maintenance hemodialysis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asbin abdul aziz |
| Designation |
Registrar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Nephrology, Kasturba Medical College, Madhav Nagar, Manipal-576104, Udupi district, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9008396720 |
| Fax |
|
| Email |
drasbinaziz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shankar Prasad |
| Designation |
Professor, HOD |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No 15, First floor OPD Block
Department of Nephrology
Kasturba Medical College, Madhav Nagar
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9739905443 |
| Fax |
|
| Email |
shankar.prasad@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asbin abdul aziz |
| Designation |
Registrar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Nephrology, Kasturba Medical College, Madhav Nagar, Manipal-576104, Udupi district, Karnataka, India
KARNATAKA
576104
India |
| Phone |
9008396720 |
| Fax |
|
| Email |
drasbinaziz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Asbin Abdul Aziz |
| Address |
Department of Nephrology, Kasturba Medical College, Madhav Nagar, Manipal-576104, Udupi district, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asbin aziz |
Kasturba Medical College Hospital |
Dialysis Room
3rd Floor, Kasturba Hospital Manipal,
Madhav Nagar,576104
Manipal
Udupi
KARNATAKA |
9008396720
drasbinaziz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients aged 18-80 years diagnosed as chronic kidney disease stage 5 on regular hemodialysis through upper limb AV fistula |
|
| ExclusionCriteria |
| Details |
Patients recently started on dialysis (less than three months)
Dialysis via alternative access, like hemodialysis catheter / synthetic graft
Peritoneal dialysis
Acute kidney injury
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assess the role of doppler ultrasonography in the assessment of AVFs and compare it with physical examination findings
No of secondary access failures stenosis thrombosis requiring intervention.
Kt/v less than 1.2.
Dialysis adequacy/recirculation
|
Reassess every 3 months for a total duration of 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Individual components of the primary composite outcome, i.e.,
 Access related flow issues which include stenosis, thrombosis
 Access recirculation
 Adequacy of dialysis |
1 year |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study looks at the role of doppler ultrasonography in surveillance of arteriovenous fistula in patients undergoing maintenance hemodialysis to detect early access dysfunction. |