Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R03AG060178-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper extremity arteriovenous graft (AVG) - first | Experimental | Participants randomized to receive an AVG will undergo surgery to have an AVG placed. |
|
| Upper extremity arteriovenous fistula (AVF) - first | Active Comparator | Participants randomized to receive an AVF will undergo surgery to have an AVF created. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upper arm arteriovenous graft surgery | Procedure | Creation of arteriovenous graft vascular access for hemodialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility- Eligibility for Randomization | Proportion of screened participants deemed eligible for randomization. | 12 months |
| Feasibility- Consent to Randomization | Proportion of eligible participants who consent to randomization. | 12 months |
| Feasibility- AV Graft or Fistula Placement | Proportion of participants who undergo AV graft or fistula placement within 90 days of randomization. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Strength | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| AV Access Primary Failure | 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. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mariana Murea, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27516143 | Background | Murea M, Burkart J. Finding the right hemodialysis vascular access in the elderly: a patient-centered approach. J Vasc Access. 2016 Sep 21;17(5):386-391. doi: 10.5301/jva.5000590. Epub 2016 Aug 1. | |
| 26372193 | Background | Yuo TH, Chaer RA, Dillavou ED, Leers SA, Makaroun MS. Patients started on hemodialysis with tunneled dialysis catheter have similar survival after arteriovenous fistula and arteriovenous graft creation. J Vasc Surg. 2015 Dec;62(6):1590-7.e2. doi: 10.1016/j.jvs.2015.07.076. Epub 2015 Sep 12. |
Not provided
Not provided
Individual participant data that underlie the results obtained in the pilot trial, deidentified.
Beginning 9 months and ending 36 months following the first article publication that stems from this pilot trial.
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.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Upper Extremity Arteriovenous Fistula (AVF) - First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility- Eligibility for Randomization | Proportion of screened participants deemed eligible for randomization. | Posted | Count of Participants | Participants | 12 months |
|
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| catheter-related infection | Infections and infestations | Systematic Assessment | one had a catheter-related infection |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mariana Murea, MD | Wake Forest University Health Sciences | 336-716-5777 | mmurea@wakehealth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2020 | Sep 21, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2020 | Sep 21, 2022 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Upper arm arteriovenous fistula surgery | Procedure | Creation of arteriovenous fistula vascular access for hemodialysis |
|
| 3 and 6 months |
| Patient Satisfaction With Vascular Access | 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 and 6 months |
| Performance on Activities of Daily Living (ADLs) | 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. | Baseline and 6 months |
| Performance on Activities of Instrumental Daily Living ADLs (IADLs) | The level of independence will be evaluated using IADLs instruments. ADL score range 0-31, with higher scores denoting more dependence on other people. | Baseline, 3 and 6 months |
| Depression | 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. | 3 and 6 months |
| Health-related Quality of Life (HRQoL) - Mental Health (MCS-12) Scores | 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. | Baseline, Month 3, and Month 6 |
| Health-related Quality of Life (HRQoL) - Physical Health (PCS-12) Scores | 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. | 3 and 6 months |
| Physical Activity Level | 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. | 3 and 6 months |
| Physical Activity Level 4-meter Gait | The 4MGS test is a simple screening test and a useful predictor of worsening daily activity in patients with chronic respiratory diseases. | Baseline, month 3 and 6 |
| Number of Subjects With No Pain at the AV Access Site | 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." | Baseline, 3 and 6 months |
| Number of Subjects With Mild Pain at the AV Access Site | 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." | Baseline, Month 3 and Month 6 |
| Number of Subject With Moderate Pain at the AV Access Site | 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." | Baseline, Month 3 and Month 6 |
| Number of Subjects With Severe Pain at the AV Access Site | 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." | Baseline, Month 3 and Month 6 |
| AV Access Infection | 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. | 12 months |
| AV Access Successful Cannulation | 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). | 6 months |
| AV Access Secondary Failure | 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. | 12 months |
| AV Access Procedures - Number of Surgical Re-intervention on Index AV Access Procedures | 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. | 12 months |
| AV Access Procedures - Number of Endovascular Interventions on Index AV Procedures Access | 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. | 12 months |
| 16988062 | Background | Lok CE, Allon M, Moist L, Oliver MJ, Shah H, Zimmerman D. Risk equation determining unsuccessful cannulation events and failure to maturation in arteriovenous fistulas (REDUCE FTM I). J Am Soc Nephrol. 2006 Nov;17(11):3204-12. doi: 10.1681/ASN.2006030190. Epub 2006 Sep 20. |
| 18235150 | Background | Peterson WJ, Barker J, Allon M. Disparities in fistula maturation persist despite preoperative vascular mapping. Clin J Am Soc Nephrol. 2008 Mar;3(2):437-41. doi: 10.2215/CJN.03480807. Epub 2008 Jan 30. |
| 26254301 | Background | Woo K, Goldman DP, Romley JA. Early Failure of Dialysis Access among the Elderly in the Era of Fistula First. Clin J Am Soc Nephrol. 2015 Oct 7;10(10):1791-8. doi: 10.2215/CJN.09040914. Epub 2015 Aug 7. |
| 16813989 | Background | Vascular Access 2006 Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S176-247. doi: 10.1053/j.ajkd.2006.04.029. No abstract available. |
| 23813216 | Background | DeSilva RN, Patibandla BK, Vin Y, Narra A, Chawla V, Brown RS, Goldfarb-Rumyantzev AS. Fistula first is not always the best strategy for the elderly. J Am Soc Nephrol. 2013 Jul;24(8):1297-304. doi: 10.1681/ASN.2012060632. Epub 2013 Jun 27. |
| 19670174 | Background | Richardson AI 2nd, Leake A, Schmieder GC, Biuckians A, Stokes GK, Panneton JM, Glickman MH. Should fistulas really be first in the elderly patient? J Vasc Access. 2009 Jul-Sep;10(3):199-202. doi: 10.1177/112972980901000311. |
| 33851120 | Derived | Robinson T, Geary RL, Davis RP, Hurie JB, Williams TK, Velazquez-Ramirez G, Moossavi S, Chen H, Murea M. Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial. Kidney Med. 2021 Feb 10;3(2):248-256.e1. doi: 10.1016/j.xkme.2020.11.016. eCollection 2021 Mar-Apr. |
| 32551134 | Derived | Murea M, Geary RL, Houston DK, Edwards MS, Robinson TW, Davis RP, Hurie JB, Williams TK, Velazquez-Ramirez G, Bagwell B, Tuttle AB, Moossavi S, Rocco MV, Freedman BI, Williamson JD, Chen H, Divers J. A randomized pilot study to evaluate graft versus fistula vascular access strategy in older patients with advanced kidney disease: results of a feasibility study. Pilot Feasibility Stud. 2020 Jun 17;6:86. doi: 10.1186/s40814-020-00619-9. eCollection 2020. |
| Adverse Event |
|
| Received different surgery |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Feasibility- Consent to Randomization | Proportion of eligible participants who consent to randomization. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Feasibility- AV Graft or Fistula Placement | Proportion of participants who undergo AV graft or fistula placement within 90 days of randomization. | Posted | Count of Participants | Participants | Day 90 |
|
|
|
| Secondary | Upper Extremity Strength | 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. | Subject could not move hand from past stroke; Subject had joint pain; not completed due to distance | Posted | Mean | Standard Deviation | kilograms | 3 and 6 months |
|
|
|
| Secondary | Patient Satisfaction With Vascular Access | 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. | Number differ form total number of randomized, 1 participant expired, not all questionnaires collected | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
| Secondary | Performance on Activities of Daily Living (ADLs) | 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. | Patients declined survey | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
|
|
| Secondary | Performance on Activities of Instrumental Daily Living ADLs (IADLs) | The level of independence will be evaluated using IADLs instruments. ADL score range 0-31, with higher scores denoting more dependence on other people. | Patients declined survey | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 and 6 months |
|
|
|
| Secondary | Depression | 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. | Not Posted | 3 and 6 months | Participants |
| Secondary | Health-related Quality of Life (HRQoL) - Mental Health (MCS-12) Scores | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3, and Month 6 |
|
|
|
| Secondary | Health-related Quality of Life (HRQoL) - Physical Health (PCS-12) Scores | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 and 6 months |
|
|
|
| Secondary | Physical Activity Level | 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. | Not Posted | 3 and 6 months | Participants |
| Secondary | Physical Activity Level 4-meter Gait | The 4MGS test is a simple screening test and a useful predictor of worsening daily activity in patients with chronic respiratory diseases. | Assessment was added on 2.4.2019 - Subjects could not walk un-assisted | Posted | Mean | Standard Deviation | meters per second | Baseline, month 3 and 6 |
|
|
|
| Secondary | Number of Subjects With No Pain at the AV Access Site | 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." | Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance | Posted | Count of Participants | Participants | Baseline, 3 and 6 months |
|
|
|
| Secondary | Number of Subjects With Mild Pain at the AV Access Site | 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." | Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance | Posted | Count of Participants | Participants | Baseline, Month 3 and Month 6 |
|
|
|
| Secondary | Number of Subject With Moderate Pain at the AV Access Site | 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." | Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance | Posted | Count of Participants | Participants | Baseline, Month 3 and Month 6 |
|
|
|
| Secondary | Number of Subjects With Severe Pain at the AV Access Site | 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." | Patient expired, some participants also declined (at times) answering questions, and some visits were not performed due to travel distance | Posted | Count of Participants | Participants | Baseline, Month 3 and Month 6 |
|
|
|
| Other Pre-specified | AV Access Primary Failure | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | AV Access Infection | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | AV Access Successful Cannulation | 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). | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | AV Access Secondary Failure | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | AV Access Procedures - Number of Surgical Re-intervention on Index AV Access Procedures | 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. | Posted | Number | procedures per 100 patient-days | 12 months |
|
|
|
| Other Pre-specified | AV Access Procedures - Number of Endovascular Interventions on Index AV Procedures Access | 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. | Posted | Number | procedures per 100 patient-days | 12 months |
|
|
|
| 3 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | 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 | 2 | 21 | 0 | 21 | 0 | 21 |
|
Not provided
Not provided
| D052801 | Male Urogenital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 6 Months |
|
|
| Baseline |
|
|
| 6 Months |
|
|
| week 2 |
|
|
| Month 6 |
|
|
| Month 6 |
|
|
| Baseline |
|
| Baseline |
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 3 |
|
|
| Month 6 |
|
|