| CTRI Number |
CTRI/2020/06/025553 [Registered on: 02/06/2020] Trial Registered Prospectively |
| Last Modified On: |
31/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To check the failure rate of matured arteriovenous fistula which is used for dialysis. |
|
Scientific Title of Study
|
Surveillance to assess the secondary failure of matured arteriovenous fistula |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANOJPRABHAKARAN |
| Designation |
DM STUDENT FIRST YEAR |
| Affiliation |
ABVIMS DRRML HOSPITAL |
| Address |
DEPARTMENT OF NEPHROLOGY
ABVIMS DRRML HOSPITAL
NEW DELHI
New Delhi
DELHI
110001
India |
| Phone |
9176041018 |
| Fax |
|
| Email |
manojbchml@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRProf HIMANSHU SEKHAR MAHAPATRA |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
ABVIMS DRRML HOSPITAL |
| Address |
DEPARTMENT OF NEPHROLOGY
ABVIMS DRRML HOSPITAL
NEW DELHI
DEPARTMENT OF NEPHROLOGY ABVIMS DRRML HOSPITALNEW DELHI
New Delhi
DELHI
110001
India |
| Phone |
9968474805 |
| Fax |
|
| Email |
hsmnephro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANOJPRABHAKARAN |
| Designation |
DM Student first year |
| Affiliation |
ABVIMS DRRML HOSPITAL |
| Address |
Department of Nephrology
ABVIMS DRRML HOSPITAL
NEW DELHI
New Delhi
DELHI
110001
India |
| Phone |
9176041018 |
| Fax |
|
| Email |
manojbchml@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG thesis -Department of Nephrology , DR.Ram Manohar lohia hospital & Atal Bihari Vajpayee Institue of Medical Sciences, NEW DELH 110001. |
|
|
Primary Sponsor
|
| Name |
Department of Nephrology |
| Address |
Dr.Ram Manohar Lohia hospital & Atal Bihari Vajpayee Institute of Medical sciences New delhi |
| Type of Sponsor |
Government medical college |
|
|
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 MANOJPRABHAKARAN |
DR RML HOSPITAL |
Nephrology OPD S1 TO 4 , DIALYSIS ROOM ROOM 10, Department of Nephrology
New Delhi
DELHI |
9176041018
manojbchml@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABVIMS,DR RML HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient who are CKD 4/5 who are having arteriovenous fistula |
|
| ExclusionCriteria |
| Details |
VASCULAR GANGRENE |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the secondary failure rate of matured arteriovenous fistula |
at 3rd month and at 6th month after arteriovenous fistula creation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the sensitivity and specificity of methods used to for assessing the arteriovenous fistula i.e. clinical examination doppler ultrasound and fistulogram |
at 3rd month and at 6th month after arteriovenous fistula creation |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="88" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2020 |
| Date of Study Completion (India) |
24/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
yet to publish, in analysis stage |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Arteriovenous fistula (AVF) remains both a lifeline and an achilles heel for patients receiving hemodialysis therapy . The primary aim of AVF surveillance is to identify a potential problem that could lead to access failure . Hence the current study was planned to see the secondary AVF failure rate and also planned to compare sensitivity and specificity of methods of vascular access surveillance i.e. clinical examination, USG doppler and fistulogram in detecting the secondary failure rate. |