To study the consequences of doing dilatation of vein using saline jet plus balloon catheter versus saline jet plus malleable metal dilator in small calibre veins (2mm or less) and their impact on surgically created connection between artery and vein that is required for performing dialysis.
- Conditions
- Health Condition 1: null- Chronic Kidney Disease type V patients visiting surgery clinic for creation of Arterio venous fistula forthe purpose of haemodialysis
- Registration Number
- CTRI/2017/05/008543
- Lead Sponsor
- Departmental Funds Study trial is funded by Department of Surgical Disciplines AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. CKD 4-5 patients visiting surgery clinic for creation of AVF for haemodialysis
2. 18 to 65 years of age both male and female
3. Radial artery with normal duplex ultrasound (DUS) parameters
4. Luminal diameter of vein <= 2mm or when 2.0-mm coronary dilator could not be easily passed into the cephalic vein (draining vein)
5. Sufficient backflow could not be confirmed after venotomy
6. Patient can follow instructions
7. Patients are ready for regular follow up
8. unable to provide informed written consent
1. History of previous surgery on vessels in the ipsilateral upper limb
2. Ipsilateral central venous stenosis or occlusions of vein that is not amenable to correction
3. Vein diameter > 2.0-mm or when 2mm coronary dilator can be easily passed through cephalic vein.
4. Segmental or complete occlusion of vein detected on preoperative duplex ultrasonography.
5. Steal syndrome requiring surgical ligation.
6. Vessels that are too frail to be cannulated.
7. Vein is injured due to cannulation or surgical procedure (e.g., perforation of vein and bleeding).
8. Brachial artery or radial artery extensive disease (calcified or atherosclerosed artery) detected on preoperative DUS.
9. absence of bruit after arterio-venous fistula surgery
10. Non-compliance with medical care or follow up
11. Patient suffering from psychiatry problems
12. Unable to give consent or patient refusal
13. Medical risk factors
• Hypertension - SBP >180, DBP >90;
• Hypotension - SBP <90, DBP <60
• NYHC IV heart failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Six-month primary patency rate <br/ ><br>2. Maturation of AV fistulaTimepoint: day 2 <br/ ><br>week 4 <br/ ><br>week 8 <br/ ><br>week 24
- Secondary Outcome Measures
Name Time Method 1. Re-intervention rates <br/ ><br>2. Cost of treatmentTimepoint: week 24