| CTRI Number |
CTRI/2025/06/088679 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cannulation technique in arteriovenous fistula in hemodilaysis patients] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative analysis of MUST cannulation technique and conventional cannulation techniques for arteriovenous fistula in chronic kidney disease patients-an experimental study |
|
Scientific Title of Study
|
Multiple Single Cannulation Technique of Arteriovenous Fistula a randomized controlled study in a tertiary care centre |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Keerthana T |
| Designation |
post graduate in Nephrology |
| Affiliation |
Stanley Medical College and Hospital |
| Address |
Dept of Nephrology, Stanley Medical College, old jail road, George Town, Chennai
Chennai TAMIL NADU 600001 India |
| Phone |
9962292634 |
| Fax |
|
| Email |
keerthiiikool@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Keerthana T |
| Designation |
post graduate in Nephrology |
| Affiliation |
Stanley Medical College and Hospital |
| Address |
Dept of Nephrology, Stanley Medical College, old jail road, George Town, Chennai
Chennai TAMIL NADU 600001 India |
| Phone |
9962292634 |
| Fax |
|
| Email |
keerthiiikool@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Edwin Fernando |
| Designation |
professor and HOD of nephrology |
| Affiliation |
stanley medical college and hospital |
| Address |
3rd floor,emergency building,Department of Nephrology,stanley medical college and hospital, old jail road, chennai
Chennai TAMIL NADU 600001 India |
| Phone |
9841018717 |
| Fax |
|
| Email |
nephroeddy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Keerthana T |
| Address |
Dept of Nephrology,Stanley Medical College, old jail road, George Town, Chennai-600001 |
| 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 Keerthana T |
Stanley Medical College |
Dept of Nephrology, G-block,3rd floor,Old Jail Road, Chennai-600001, Tamil Nadu, India Chennai TAMIL NADU |
9962292634
keerthiiikool@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| government stanley medical college and hospital, chennai-01 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R938||Abnormal findings on diagnostic imaging of other specified body structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional cannulation technique |
conventional cannulation technique for arteriovenous fistula in Hemodialysis patients for 1 year |
| Intervention |
multiple single cannulation technique(must) |
multiple single cannulation technique(must)for arteriovenous fistula(AVF) in hemodialysis patients for 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
chronic kidney disease with arteriovenous fistula done within 3 months is interventional group |
|
| ExclusionCriteria |
| Details |
arteriovenous fistula in chronic kidney disease with hematoma, thrombosis, bleeding or patients having grafts. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the cannulation technique of MuST with conventional cannulation techniques in terms of AVF survival and any AVF complications determined by doppler of arteriovenous fistula |
Assess the AVF survival with help of Doppler of AVF baseline, 4 weeks, 8 weeks, 12 weeks , 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
25/06/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Arteriovenous fistula (AVF) is called as “Achilles heel of dialysis”. Without a good AVF, a chronic kidney disease (CKD5D) patient’s dialysis adequacy decreases and morbidity and mortality greatly increases. Cannulation technique (CT) is key factor in maintaining a good AVF. A new approach to AVF cannulation with noticeable benefits to patients is the Multiple Single cannulation technique (MuST). MuST is a new modified CT combining the techniques of traditional Rope ladder and button hole techniques. This CT consists of rotating the same six specific cannulation sites, three arterial and three venous puncture sites through two or three treatment days each week. Though this technique has been there since 2013, the technique’s efficacy hasn’t been well explored and its efficacy hasn’t been properly compared with traditional CT in literature. This is a non-randomized open label comparative study comparing MuST cannulation and conventional cannulation technique in terms of AVF survival and complications resulting in missed cannulation. AVF survival is measured by doppler ultrasonogram of AVF to determine the flow volume in AVF. Study will be conducted at hemodialysis unit at Department of Nephrology, Stanley Medical College, Chennai. Inclusion criteria is CKD5D on Maintainence hemodialysis with a Arteriovenous Fistula (AVF) previously cannulated within 3 months or new AVF without any vascular access complications with good flow rate of > 600 ml/min and good segment length of 6 cm for cannulation for interventional group. For control group, patients who don’t fit into interventional group criteria and who are already on dialysis and cannulated by conventional method. Exclusion criteria is CKD5D patients on arteriovenous grafts, AVF with thrombus, infections, immature AVF or central venous stenosis. Outcomes are comparison of AVF survival in both groups and access the AVF complications in interventional group. |