Chronic kidney disease (CKD) stage 4 ESRD CKD ESRD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: CKD stage 4 and 5 who planning for hemodialysisvia AVF 1 Brachial artery ≥ 2 mm at cubital fossa 2 Anatomical variations of cubital superficial vein type 1 or 2 3 Cephalic vein ≥ 2.5 mm at cubital fossa with good continuity to cephalic arch and compressible 4 MABV or MCV ≥ 2.5 mm at cubital fossa with good continuity and compressible for cubital fossa 5 No evidence of Ipsilateral CVOD (Axillary vein to SVC) 6 Ipsilateral Upper extremity PAD
Exclusion criteria
Exclusion criteria: 1 Unfit for Surgery (*ASA Physical status Classification system class 4-6) 2 Bleeding tendency 3 History of bilateral AVF creation at cubital fossa area 4 Candidated for radiocephalic wrist AVF 5 Target outflow vein (Cephalic vein, MABV or MCV not patent intraoperatively)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth rate of Outflow Cephalic vein segment diameter at 4, 6, 8, 12, 16 weeks after end of the intervention Mean of cephalic vein diameter/time,Increasing of access flow rate (Qa) at 4, 6, 8, 12, 16 weeks after end of the intervention Mean of access flow rate/time | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 months proportion of AVF Maturation at 3 months after end of the intervention Matured AVF / All AVF in each AVF creation method ,AVF creation to Maturation time at 4, 6, 8, 12, 16 weeks after end of the intervention time between day of AVF creation and AVF maturation,AVF creation to first successful use time (Subgroup analysis for CKD stage 5 or ESRD) time to events time between day of AVF creation and AVF cannulation,Brachial artery flow at 4, 6, 8, 12, 16 weeks after end of the intervention Duplex ultrasound to measured flow rate of AVF,Brachial artery diameter at 4, 6, 8, 12, 16 weeks after end of the intervention Duplex ultrasound to measured diameter of brachial artery,Post-operative complication at 4, 6, 8, 12, 16 weeks after end of the intervention Clinical examination and further investigation such as duplex ultrasound as need | — |
Countries
Thailand
Contacts
Department of Surgery, Faculty of Medicine, Thammasat University Hospital.