Trial Outcomes & Findings for Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease (NCT NCT03545113)
NCT ID: NCT03545113
Last Updated: 2022-11-21
Results Overview
Proportion of screened participants deemed eligible for randomization.
COMPLETED
NA
44 participants
12 months
2022-11-21
Participant Flow
Participant milestones
| Measure |
Upper Extremity Arteriovenous Graft (AVG) - First
Participants randomized to receive an AVG will undergo surgery to have an AVG placed.
Upper arm arteriovenous graft surgery: Creation of arteriovenous graft vascular access for hemodialysis
|
Upper Extremity Arteriovenous Fistula (AVF) - First
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Upper Extremity Arteriovenous Graft (AVG) - First
Participants randomized to receive an AVG will undergo surgery to have an AVG placed.
Upper arm arteriovenous graft surgery: Creation of arteriovenous graft vascular access for hemodialysis
|
Upper Extremity Arteriovenous Fistula (AVF) - First
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Overall Study
Surgery Cancelled
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Received different surgery
|
1
|
0
|
Baseline Characteristics
Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease
Baseline characteristics by cohort
| Measure |
Upper Extremity Arteriovenous Graft (AVG) - First
n=23 Participants
Participants randomized to receive an AVG will undergo surgery to have an AVG placed.
Upper arm arteriovenous graft surgery: Creation of arteriovenous graft vascular access for hemodialysis
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=21 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.8 years
n=5 Participants
|
78.9 years
n=7 Participants
|
76.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsProportion of screened participants deemed eligible for randomization.
Outcome measures
| Measure |
Total Group
n=77 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Feasibility- Eligibility for Randomization
|
54 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 monthsProportion of eligible participants who consent to randomization.
Outcome measures
| Measure |
Total Group
n=54 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Feasibility- Consent to Randomization
|
44 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 90Proportion of participants who undergo AV graft or fistula placement within 90 days of randomization.
Outcome measures
| Measure |
Total Group
n=23 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=21 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Feasibility- AV Graft or Fistula Placement
|
18 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 3 and 6 monthsPopulation: Subject could not move hand from past stroke; Subject had joint pain; not completed due to distance
The grip-strength test will be performed twice on each hand for each assessment and the mean of the two results will be used for statistical analyses; a cut-off point \<16 kg in women and \<26 kg in men will define muscle weakness. Changes in grip strength will be compared between the two access interventions. Assessed with upper arm grip-strength test in each arm using a hand-held dynamometer.
Outcome measures
| Measure |
Total Group
n=13 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=16 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Upper Extremity Strength
3 Months
|
21.3 kilograms
Standard Deviation 5.6
|
22.6 kilograms
Standard Deviation 6.4
|
|
Upper Extremity Strength
6 Months
|
19.1 kilograms
Standard Deviation 6.7
|
20.4 kilograms
Standard Deviation 7.2
|
|
Upper Extremity Strength
Baseline
|
19.6 kilograms
Standard Deviation 3.3
|
17.4 kilograms
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 3 and 6 monthsPopulation: Number differ form total number of randomized, 1 participant expired, not all questionnaires collected
Vascular access questionnaire will be used to assess differences in patient satisfaction with vascular access between the two access interventions using the short-form vascular access questionnaire (SF-VAQ). Mean scores obtained on SF-VAQ will be compared. SF-VAQ score range 4 -20 with higher scores indicating more satisfaction with the vascular access.
Outcome measures
| Measure |
Total Group
n=16 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=19 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Patient Satisfaction With Vascular Access
3 months
|
9.75 score on a scale
Standard Deviation 3.45
|
8.82 score on a scale
Standard Deviation 1.53
|
|
Patient Satisfaction With Vascular Access
6 Months
|
7.55 score on a scale
Standard Deviation 2.74
|
8.75 score on a scale
Standard Deviation 1.16
|
|
Patient Satisfaction With Vascular Access
week 2
|
10.1 score on a scale
Standard Deviation 3.18
|
9.21 score on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Patients declined survey
The level of independence will be evaluated using ADLs. ADL score range 0-30, with higher scores denoting more dependence on other people to perform the usual daily activities.
Outcome measures
| Measure |
Total Group
n=17 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=17 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Performance on Activities of Daily Living (ADLs)
Baseline
|
4.5 score on a scale
Standard Deviation 1.6
|
4.75 score on a scale
Standard Deviation 1.28
|
|
Performance on Activities of Daily Living (ADLs)
Month 6
|
4.2 score on a scale
Standard Deviation 1.82
|
5.11 score on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsPopulation: Patients declined survey
The level of independence will be evaluated using IADLs instruments. ADL score range 0-31, with higher scores denoting more dependence on other people.
Outcome measures
| Measure |
Total Group
n=14 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=17 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Performance on Activities of Instrumental Daily Living ADLs (IADLs)
Baseline
|
5.28 score on a scale
Standard Deviation 2.49
|
4.5 score on a scale
Standard Deviation 1.45
|
|
Performance on Activities of Instrumental Daily Living ADLs (IADLs)
Month 6
|
4.4 score on a scale
Standard Deviation 2.65
|
6.42 score on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: 3 and 6 monthsDepression scores assessed with the patient health questionnaire (PHQ-9) will be compared between the two vascular access arms. PHQ-9 score range 0-27. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 3, and Month 6The impact of the two types of vascular access on HRQoL will be assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF) version 1.3. which consists of a generic core (Short Form-36 \[SF-36\]) and an 11-item kidney disease-specific scale. Score range 0 to 100, with higher scores reflecting better quality of life.
Outcome measures
| Measure |
Total Group
n=15 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=19 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Health-related Quality of Life (HRQoL) - Mental Health (MCS-12) Scores
Month 3
|
54.38 score on a scale
Standard Deviation 13.26
|
46.27 score on a scale
Standard Deviation 5.66
|
|
Health-related Quality of Life (HRQoL) - Mental Health (MCS-12) Scores
Month 6
|
53.79 score on a scale
Standard Deviation 17.31
|
58.2 score on a scale
Standard Deviation 5.91
|
|
Health-related Quality of Life (HRQoL) - Mental Health (MCS-12) Scores
Baseline
|
53.38 score on a scale
Standard Deviation 8.05
|
51.46 score on a scale
Standard Deviation 11.37
|
SECONDARY outcome
Timeframe: 3 and 6 monthsThe impact of the two types of vascular access on HRQoL will be assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF) version 1.3. which consists of a generic core (Short Form-36 \[SF-36\]) and an 11-item kidney disease-specific scale. Score range 0 to 100, with higher scores reflecting better quality of life.
Outcome measures
| Measure |
Total Group
n=15 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=19 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Health-related Quality of Life (HRQoL) - Physical Health (PCS-12) Scores
Month 3
|
39.02 score on a scale
Standard Deviation 8.45
|
39.44 score on a scale
Standard Deviation 5.23
|
|
Health-related Quality of Life (HRQoL) - Physical Health (PCS-12) Scores
Month 6
|
40.77 score on a scale
Standard Deviation 7.73
|
36.12 score on a scale
Standard Deviation 5.55
|
|
Health-related Quality of Life (HRQoL) - Physical Health (PCS-12) Scores
Baseline
|
29.89 score on a scale
Standard Deviation 12.09
|
36.75 score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: 3 and 6 monthsThe Rapid Assessment of Physical Activity (RAPA) instrument will be used to assess habitual physical activity. RAPA test score ≤ 3 corresponded to a sedentary lifestyle or a very light activity level; values ≥4 indicated a moderate to vigorous active lifestyle.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, month 3 and 6Population: Assessment was added on 2.4.2019 - Subjects could not walk un-assisted
The 4MGS test is a simple screening test and a useful predictor of worsening daily activity in patients with chronic respiratory diseases.
Outcome measures
| Measure |
Total Group
n=5 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=10 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Physical Activity Level 4-meter Gait
Baseline
|
7.5 meters per second
Standard Deviation 3.04
|
5.1 meters per second
Standard Deviation 1.61
|
|
Physical Activity Level 4-meter Gait
Month 3
|
6.88 meters per second
Standard Deviation 2.23
|
6.04 meters per second
Standard Deviation 2.36
|
|
Physical Activity Level 4-meter Gait
Month 6
|
5.74 meters per second
Standard Deviation 1.15
|
6.34 meters per second
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline, 3 and 6 monthsPopulation: Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance
This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: "no pain," "mild pain," "moderate pain," "severe pain," or "pain as bad as it could be."
Outcome measures
| Measure |
Total Group
n=17 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=19 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Number of Subjects With No Pain at the AV Access Site
Baseline
|
6 Participants
|
13 Participants
|
|
Number of Subjects With No Pain at the AV Access Site
Month 3
|
4 Participants
|
10 Participants
|
|
Number of Subjects With No Pain at the AV Access Site
Month 6
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3 and Month 6Population: Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance
This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: "no pain," "mild pain," "moderate pain," "severe pain," or "pain as bad as it could be."
Outcome measures
| Measure |
Total Group
n=17 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=19 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Number of Subjects With Mild Pain at the AV Access Site
Baseline
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Mild Pain at the AV Access Site
Month 3
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Mild Pain at the AV Access Site
Month 6
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3 and Month 6Population: Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance
This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: "no pain," "mild pain," "moderate pain," "severe pain," or "pain as bad as it could be."
Outcome measures
| Measure |
Total Group
n=17 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=19 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Number of Subject With Moderate Pain at the AV Access Site
Baseline
|
3 Participants
|
5 Participants
|
|
Number of Subject With Moderate Pain at the AV Access Site
Month 3
|
2 Participants
|
0 Participants
|
|
Number of Subject With Moderate Pain at the AV Access Site
Month 6
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3 and Month 6Population: Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance
This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: "no pain," "mild pain," "moderate pain," "severe pain," or "pain as bad as it could be."
Outcome measures
| Measure |
Total Group
n=17 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=19 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Number of Subjects With Severe Pain at the AV Access Site
Baseline
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Severe Pain at the AV Access Site
Month 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Severe Pain at the AV Access Site
Month 6
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsRate of AV access primary failure between the two AV access strategies. Primary access failure is defined as permanent failure of the fistula or graft before hemodialysis suitability. This will include inadequate maturation, thrombosis, failure of first and subsequent cannulations, and/or other complications leading to nonfunctional fistula or graft.
Outcome measures
| Measure |
Total Group
n=13 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=16 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
AV Access Primary Failure
|
4 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsIncidence rate of AV access infection between the two AV access strategies. This will include fistula or graft cellulitis, abscess, and/or bacteremia due to AV access infection.
Outcome measures
| Measure |
Total Group
n=13 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=16 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
AV Access Infection
|
3 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsWill compare the proportion of patients with successful AV access cannulation between the two AV access strategies. Successful cannulation is defined by the use of the AV access as the primary vascular access for hemodialysis (the fistula or graft access has been cannulated with two 16- or 15-gauge needles for ≥3 consecutive dialysis sessions and the dialysis central venous catheter was removed).
Outcome measures
| Measure |
Total Group
n=13 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=16 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
AV Access Successful Cannulation
|
8 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsRate of AV access secondary failure between the two AV access strategies. Secondary access failure is defined by permanent AV access failure after the fistula or graft met dialysis suitability criteria with subsequent abandonment.
Outcome measures
| Measure |
Total Group
n=18 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=21 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
AV Access Secondary Failure
|
5 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsNumber of AV access procedures per 100 patient-days between the two AV access strategies. This will include angioplasty, thrombectomy, stent placement, repeat surgery, and/or surgical superficialization.
Outcome measures
| Measure |
Total Group
n=13 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=16 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
AV Access Procedures - Number of Surgical Re-intervention on Index AV Access Procedures
|
3 procedures per 100 patient-days
|
4 procedures per 100 patient-days
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsNumber of AV access procedures per 100 patient-days between the two AV access strategies. This will include angioplasty, thrombectomy, stent placement, repeat surgery, and/or surgical superficialization.
Outcome measures
| Measure |
Total Group
n=13 Participants
Group includes all Participants that signed Consent
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=16 Participants
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
AV Access Procedures - Number of Endovascular Interventions on Index AV Procedures Access
|
5 procedures per 100 patient-days
|
7 procedures per 100 patient-days
|
Adverse Events
Upper Extremity Arteriovenous Graft (AVG) - First
Upper Extremity Arteriovenous Fistula (AVF) - First
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Upper Extremity Arteriovenous Graft (AVG) - First
n=23 participants at risk
Participants randomized to receive an AVG will undergo surgery to have an AVG placed.
Upper arm arteriovenous graft surgery: Creation of arteriovenous graft vascular access for hemodialysis
|
Upper Extremity Arteriovenous Fistula (AVF) - First
n=21 participants at risk
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Upper arm arteriovenous fistula surgery: Creation of arteriovenous fistula vascular access for hemodialysis
|
|---|---|---|
|
Infections and infestations
catheter-related infection
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/21 • 12 months
|
Additional Information
Mariana Murea, MD
Wake Forest University Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place