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Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease (GEMSSTAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03545113
Recruitment Status : Active, not recruiting
First Posted : June 4, 2018
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
Many older adults require hemodialysis for advanced chronic kidney disease, but it is not clear which permanent vascular access method (fistula or graft) is best with respect to access effectiveness and patient satisfaction. In this pilot study, the study team will test the hypothesis that older adults undergoing graft access placement will more effectively transition from catheter-based to arteriovenous access-based hemodialysis; have fewer following vascular access procedures; have better upper extremity function; have better self-sufficiency with daily activities; and better health-related quality of life compared to those who undergo arteriovenous fistula access placement. The study will establish feasibility of randomizing older adults to the two types of arteriovenous access surgeries; evaluate relationships between measurements of pre-operative physical function and vascular access development; compare vascular access outcomes between the two groups; and gather longitudinal assessments of upper extremity muscle strength, performance of activities of daily living, and patients' reports of satisfaction with their vascular access and quality of life.

Condition or disease Intervention/treatment Phase
Kidney Diseases Procedure: Upper arm arteriovenous graft surgery Procedure: Upper arm arteriovenous fistula surgery Not Applicable

Detailed Description:
Each year, more than 600,000 people in the United States receive life-saving hemodialysis (HD) treatments for end-stage kidney disease (ESKD), a third of whom are older adults.Timely placement of an arteriovenous (AV) vascular access (native AV fistula [AVF] or prosthetic AV graft [AVG]) is necessary to avoid (or limit) the use of tunneled central venous catheters (TCVC) for HD. 'Fistula First Catheter Last' national guidelines require placement of AVF as the AV access of first choice in all patients to achieve better patient survival. However, the benefits of AVF over AVG are least certain in older adults, as age-related biological changes independently modulate patient outcomes. Nationally representative cohort studies of older adults with incident ESKD have shown similar patient survival between those whose first AV access placed or used was a fistula or a graft.Compared with grafts, fistulas fail more often and necessitate longer times and more subsequent procedures to aid development, exposing older patients to time-consuming procedures that may negatively affect upper extremity strength and erode their quality of life. The contribution of pre-operative physical function to AV access outcomes and the impact of AV access placement on upper extremity strength and self-sufficiency have not been evaluated. This pilot trial will involve older adults with pre-dialysis advanced chronic kidney disease (CKD) or incident ESKD using a TCVC for HD who had no prior AV access surgery and have upper extremity vasculature suitable for either fistula or graft placement. Participants will be randomized to receive an upper extremity AVF-first or AVG-first access for HD. The primary objective of this pilot trial is to prospectively evaluate patient and vascular access outcomes in a randomized intervention and in a patient population in whom fistula-first guidelines have been applied despite the lack of proven benefit and at the detriment of more access failures and procedures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Feasibility- Eligibility for randomization [ Time Frame: 12 months ]
    Proportion of screened participants deemed eligible for randomization.

  2. Feasibility- Consent to randomization [ Time Frame: 12 months ]
    Proportion of eligible participants who consent to randomization.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 65 years
  • End-stage kidney disease (ESKD) on chronic hemodialysis (HD)
  • Tunneled central venous catheter (TCVC) is the sole vascular access used for HD
  • Advanced chronic kidney disease (CKD) expected to require HD initiation within 90 days of screening and deemed medically necessary by the treating nephrologist to proceed with arteriovenous (AV) access placement in preparation for HD initiation
  • Did not undergo AV access placement in the past
  • Medically eligible to receive AV fistula (AVF) or AV graft (AVG) placement as deemed by the treating nephrologist
  • Surgically eligible to receive either an AVF or an AVG as deemed by the vascular surgeon
  • HD is the intended long-term modality of treatment for ESKD
  • Planning to remain within Wake Forest provided health care for at least 12 months

Exclusion Criteria:

  • Presence of an AVF or AVG
  • Previous attempt(s) for AV vascular access placement
  • Native vasculature not suitable for placement of AV access
  • Imminent transplant planned (within 6 months)
  • Anticipated life expectancy <9 months

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Mariana Murea, MD Wake Forest University Health Sciences

Additional Information:
Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03545113    
Other Study ID Numbers: IRB00050577
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results obtained in the pilot trial, deidentified.
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following the first article publication that stems from this pilot trial.
Access Criteria: Researchers who provide a methodologically sound proposal and whose proposed use of data has been approved by an independent review party identified for this purpose.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
graft
fistula
hemodialysis
Vascular access
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Fistula
Urologic Diseases
Pathological Conditions, Anatomical
Renal Insufficiency, Chronic
Renal Insufficiency