CTRI/2017/05/008543CompletedPhase 3
Hydrostatic dilatation plus balloon angioplasty versus hydrostatic dilatation plus malleable vascular dilator for 2mm or less caliber veins used during creation of arteriovenous fistula for hemodialysis. A randomized controlled trial.
Departmental Funds Study trial is funded by Department of Surgical Disciplines AIIMS New Delhi0 sites120 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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