Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | March 1, 2018 |
| End Date: | March 1, 2020 |
Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but
many of them fail to mature. The optimal timing of intervention to salvage immature AVFs is
unknown.The study proposes a randomized clinical trial comparing the clinical and economic
impact of early vs late angioplasty in non-maturing AVFs.
The study proposes a RCT to test the hypothesis that, as compared to early angioplasty of
non-maturing AVFs, late angioplasty results in a lower proportion of AVFs being used at 6
months, but a greater long-term AVF patency , lower requirement of subsequent interventions
to maintain AVF patency for dialysis, and lower overall cost of access maintenance.
many of them fail to mature. The optimal timing of intervention to salvage immature AVFs is
unknown.The study proposes a randomized clinical trial comparing the clinical and economic
impact of early vs late angioplasty in non-maturing AVFs.
The study proposes a RCT to test the hypothesis that, as compared to early angioplasty of
non-maturing AVFs, late angioplasty results in a lower proportion of AVFs being used at 6
months, but a greater long-term AVF patency , lower requirement of subsequent interventions
to maintain AVF patency for dialysis, and lower overall cost of access maintenance.
The optimal timing of intervention in non-maturing AVFs remains controversial, and can only
be definitively addressed by a randomized clinical trial (RCT) comparing early (6 weeks) vs
late (3 months) angioplasty of non-maturing AVFs. The investigators will perform a
single-center, prospective RCT. The investigators will recruit 112 patients who initiated
hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a
6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or
blood flow < 500 ml/min). These patients will be randomized to one of two groups: an early
intervention group that will undergo a routine PTA at 6 weeks after AVF creation, or a late
intervention group in which early PTA will be avoided and subsequently be performed only if
the 3-month ultrasound indicates persistent AVF immaturity. These patients will be followed
for 2 years.
be definitively addressed by a randomized clinical trial (RCT) comparing early (6 weeks) vs
late (3 months) angioplasty of non-maturing AVFs. The investigators will perform a
single-center, prospective RCT. The investigators will recruit 112 patients who initiated
hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a
6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or
blood flow < 500 ml/min). These patients will be randomized to one of two groups: an early
intervention group that will undergo a routine PTA at 6 weeks after AVF creation, or a late
intervention group in which early PTA will be avoided and subsequently be performed only if
the 3-month ultrasound indicates persistent AVF immaturity. These patients will be followed
for 2 years.
Inclusion Criteria:
- Patients with End stage renal disease (ESRD).
- Patients on hemodialysis.
- Patients using central venous catheter (CVC).
- Patients who had a new AVF created after commencing dialysis.
- Patients who had immature fistula ( 6-week postoperative ultrasound that revealed an
immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min).
Exclusion Criteria:
• Children with Age below 18
We found this trial at
1
site
Click here to add this to my saved trials
