Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease (GEMSSTAR)
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|ClinicalTrials.gov Identifier: NCT03545113|
Recruitment Status : Active, not recruiting
First Posted : June 4, 2018
Last Update Posted : May 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Kidney Diseases||Procedure: Upper arm arteriovenous graft surgery Procedure: Upper arm arteriovenous fistula surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Pilot Study Comparing Graft-first to Fistula-first Strategies in Older Patients With Incident End-stage Kidney Disease|
|Actual Study Start Date :||September 4, 2018|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
Experimental: Upper extremity arteriovenous graft (AVG) - first
Participants randomized to receive an AVG will undergo surgery to have an AVG placed.
Procedure: Upper arm arteriovenous graft surgery
Creation of arteriovenous graft vascular access for hemodialysis
Active Comparator: Upper extremity arteriovenous fistula (AVF) - first
Participants randomized to receive an AVF will undergo surgery to have an AVF created.
Procedure: Upper arm arteriovenous fistula surgery
Creation of arteriovenous fistula vascular access for hemodialysis
- Feasibility- Eligibility for randomization [ Time Frame: 12 months ]Proportion of screened participants deemed eligible for randomization.
- Feasibility- Consent to randomization [ Time Frame: 12 months ]Proportion of eligible participants who consent to randomization.
- Feasibility- AV graft or fistula placement [ Time Frame: 12 months ]Proportion of participants who undergo AV graft or fistula placement within 90 days of randomization.
- Upper extremity strength [ Time Frame: 3 and 6 months ]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.
- Patient satisfaction with vascular access [ Time Frame: 3 and 6 months ]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.
- Performance on activities of daily living (ADLs) [ Time Frame: 3 and 6 months ]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.
- Performance on activities of instrumental daily living ADLs (IADLs) [ Time Frame: 3 and 6 months ]The level of independence will be evaluated using IADLs instruments. ADL score range 0-31, with higher scores denoting more dependence on other people.
- Depression [ Time Frame: 3 and 6 months ]Depression 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.
- Health-related quality of life (HRQoL) [ Time Frame: 3 and 6 months ]The 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.
- Physical activity level [ Time Frame: 3 and 6 months ]The 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.
- Pain at the AV access site [ Time Frame: 3 and 6 months ]This will be determined by using the Verbal Descriptor Scale (VDS). Participants are asked to rate their pain as absent, mild, moderate and severe.
- AV access primary failure [ Time Frame: 6 months ]Rate 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.
- AV access infection [ Time Frame: 12 months ]Incidence 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.
- AV access successful cannulation [ Time Frame: 6 months ]Will 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).
- AV access secondary failure [ Time Frame: 12 months ]Rate 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.
- AV access procedures [ Time Frame: 12 months ]Number 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545113
|United States, North Carolina|
|Wake Forest Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Mariana Murea, MD||Wake Forest University Health Sciences|