Investigating local or regional anaesthesia during surgery to create a connection between an artery and a vei
- Conditions
- Patients undergoing primary (Radiocephalic fistula) RCF or (Brachiocephalic fistula) creationSurgerySurgically created arteriovenous fistula
- Registration Number
- ISRCTN14153938
- Lead Sponsor
- HS Greater Glasgow and Clyde
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34937718/ (added 30/12/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 571
1. Aged >18 years
2. End-stage renal disease (ESRD) and receiving renal replacement therapy (RRT), or chronic kidney disease (CKD) stage IV or V and referred for primary radiocephalic (RCF) or brachiocephalic (BCF) fistula creation
1. Unable or unwilling to provide informed consent
2. Preference for general or alternative anaesthesia
3. Active infection at surgical or anaesthetic site
4. Previous ipsilateral arteriovenous fistula (AVF) creation (a previous attempt at distal AVF creation which fails immediately is not considered a contraindication, however any distal access which has previously run sufficiently to mature the outflow vein or proximal revision of an existing AVF is considered a contraindication)
5. Known ipsilateral cephalic arch or central venous stenosis (even if previously treated)
6. USS evidence of stenosis in inflow artery
7. Radial or brachial artery <1.8 mm diameter and/or cephalic vein <2 mm at wrist or <3 mm at elbow (with tourniquet) on pre-operative USS
8. Allergy to Local anaesthesia (LA) or any excipient agents
9. Acquired or inherited coagulopathy (including warfarin/ heparin/ novel oral anticoagulant use where it has not been possible to stop the anticoagulation in anticipation of surgery) and/or platelets <75 or INR >1.4
10. Significant pre-existing neurological disorder affecting the upper limb
11. Weight <45 kg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method