Health Condition 1: N184- Chronic kidney disease, stage 4 (severe) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe)
Conditions
Interventions
Intervention1: This is a prospective, randomized single blinded controlled trial designed to compare the efficacy in terms of maturation, patency and complications AV fistula receiving or not receivin
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years to 75 yrs of age with stage 4 or 5 CKD. Patients with systolic B.P. more than 100 mmHg Suitable vascular anatomy confirmed by doppler usg arterial and venous diameter more than 2 mm. Stable cardiovascular status No history of previous AV fistula creation in intended arm
Exclusion criteria
Exclusion criteria: Previous vascular surgery on target arm Inadequate arteries or veins for fistula creation (eg: severe stenosis, occlusion, calcification). H/O injection or blood sampling or injection in the arm where av fistula is to be created Patients with connective tissue disorders , vasculitis. BMIs below 18.5 or above 29.9 Pregnant and breastfeeding women were not allowed to participate Peripheral vascular diseases in the intended arm. Severe uncontrolled comorbidities like: heart failure, coagulopathy, bleeding disorders, severe diabetes with advanced neuropathy or poor wound healing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the patency rate of AVFs at 6 weeks between patients receiving perioperative LMWH and those not receiving LMWH. Timepoint: 6 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the incidence of early AVF thrombosis (within 30 days) in both groups. To evaluate & compare perioperative bleeding & hematoma formation associated with LMWH use. To determine the need for re-intervention within 3 months after AVF creation. To compare patency at 3 months between the two groups. To assess access-related infections within the first 3 months postoperatively. To evaluate serious adverse events or complications associated with perioperative LMWH. Timepoint: . Early thrombosis within 4 weeks of surgery . Other complications in 12 weeks of surgery | — |
Countries
India
Contacts
Public ContactDharmendra Kumar Pipal
All India Institute of Medical Sciences, Gorakhpur
Outcome results
None listed