Arteriovenous FistulaNCT04017806
Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation
An observational study of Arteriovenous Fistula, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Introduction Arteriovenous fistula (AVF) is the preferred hemodialysis vascular access due to its higher patency and lower infection rate. However, its major weakness is suboptimal maturation rate. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Arteriovenous Fistula
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2018to 7 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who receives surgical anastomosis of hemodialysis AVF will be included, whether the patient is a pre-dialysis patient, fresh uremic patient or who already on dialysis treatment.
Who may be able to join
- Patients with hemodialysis who receiving AVF.
- AVF created at both radial and brachial arteries
Who cannot join
- Patients at age <20 years old
- Patients who are unconscious or unable to sign the inform consent
- Patient in whom native AVF creation is shifted to arteriovenous graft placement
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
Taipei, 116
Chung-te Liu, MD, 886-970746583, 96320@wtmu.edu.tw
About this study
Official title: Study Protocol for a Prospective Observational Study Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation
Introduction Arteriovenous fistula (AVF) is the preferred hemodialysis vascular access due to its higher patency and lower infection rate. However, its major weakness is suboptimal maturation rate. Although that substantial risk factors for AVF maturation failure have been disclosed, a modifiable risk factor remains absent. While contemporary theory for AVF maturation failure focuses on disturbed wall shear stress, complicate assumtions and measurement preclude its clinical applicability. In the process of AVF maturation, elevated luminal pressure is required for outward remodeling, however, exccessively high luminal pressure may also be ditremental to AVF maturation, which remains to be defined. This study hypothesize that higher AVF luminal pressure is harmful to its maturation and investigate its potential as a modifiable factor to improve AVF maturation.
Methods and analysis This prospective study includes patients receiving surgical creation of native AVF. The exclusion criteria include age <20 years, inability to sign inform consent and failure to create native AVF deu to technical difficulty. Demographic and labboratory profile will be collected before AVF surgery. Vascular sonography will be performed within 1 week of AVF creation to measure the blood flow rates and diameters of AVF and its branched veins. The pressure gredient within AVF will be estimated from blood flow rates by Modified Bernoulli Equation. The primary outcome was spontaneous AVF maturation defined as provision of sufficient blood flow for hemodialysis within 2 months of its creation without any interventional procedures. The secondary outcome is assisted AVF mature, which is defined as AVF maturation within 2 months from its creation, which is aided by any interventional procedure before successful use of AVF.
Read more
Ethics and dissemination This study has been approved by the ethics committee and Institutional Review Board of Taipei Medical University.
Strengths and limitations
- The strength of the present study is the prospective design that allows complete collection of parameters and outcomes.
- The predictor of interest for AVF maturation is luminal pressure of AVF.
- The study assesses hemodynamic parameters of AVF and its branched veins, including diameters, flow rates, and flow volume.
- The luminal pressure of AVF will be estimated using Modified Bernoulli Equation.
- The primary outcome of the study is spontaneous AVF maturation.
Read the detailed description
Background: AVF is the preferred vascular access for maintenance hemodialysis. However, AVF is not an ideal vascular access without any drawback. Previous studies had revealed several risk factors of AVF maturation failure, including anemia, diabetes mellitus, and smoking. On the other hand, basic studies have revealed molecular pathogenic factors of AVF maturation failure, including localized inflammation, hypoxic injury, oscillating wall shear stress, uremic milieu and oxidative stress. Despite of these substantial studies exploring the role of pathogenic factors, a modifiable pathogenic factor that is applicable to improve AVF maturation remains lacking.
Maturation failure of AVF results from luminal stenosis due to neointimal hyperplasia, signifying thickening of subintimal area caused by proliferation of myofibroblast, which is remarkably stained for α-smooth muscle actin and vimentin. Neointimal hyperplasia of AVF occurs mainly at the arteriovenous junction and venous limb of AVF, where venous endothelium is exposed to non-physiologically high blood flow rate, oscillatory shear stress and pulsatile stretching strain by arterial blood flow, suggesting the role of altered hemodynamics on AVF subintimal proliferation. It has also been reported that endothelial cells from arterial and venous parts of circulation system show different genetic expression, indicating that different hemodynamic environment regulates phenotypes of endothelial cells. Therefore, it is reasonable that elevated luminal pressure may stimulate proliferation in venous endothelium of AVF and result in maturation failure. In contrast, elevated AVF luminal pressure also provides stretching force for outward remodeling, which is required for AVF maturation. Therefore, this prospective observational study is conducted to investigate the optimal AVF luminal pressure for AVF maturation, which may be modified surgically or pharmaceutically to improve AVF maturation rate.
Specific aims Aim 1: To characterize the altered blood flow rates and luminal pressures in different segments of AVF. Aim 2: To characterize the association between luminal pressures and vessel diameters of different segments of AVF. Aim 3: To investigate the association between AVF luminal pressure and AVF maturation rate. Aim 4: To investigate the association between AVF luminal pressure and known risk factors of AVF maturation failure.
Methods and analysis: This prospective observational study is mainly aimed to investigate the association between AVF luminal pressure and maturation rate. Patients who meet the following eligibility criteria are eligible for enrollment: (1) Patient at pre-dialysis or post-dialysis status who undergoes surgical creation of native AVF for hemodialysis will be included. (2) AVF created at both radial and brachial arteries are eligible for inclusion. Exclusion criteria: (1) Patients at age <20 years old will be excluded (2) Patients who are unconscious or unable to sign the inform consent will be excluded (3) Patient in whom native AVF creation is shifted to arteriovenous graft placement due to technical difficulty will be excluded from this study. The recruit of participants, collection of parameters, and confirmation of the outcomes are performed by a full-time study nurse.
Statistic methods: Continuous variables will be expressed as mean ± standard deviation, while nominal variables are expressed in frequency and percentage. Comparisons of continuous variables will be performed using the two-tailed t-test for unpaired samples or Welch's t-test as appropriate. Comparisons of nominal variables will be performed using the Chi-square test or Fisher's exact test as appropriate. Multivariate logistic regression test will be used to evaluate the association between predictor variables and outcome variables. Statistical significance will be defined by a P value of <0.05. The statistics will be performed using SAS 9.4 (SAS Institute Inc, Cary, NC, USA). G*Power 3.1.9.4 was used to estimate the sample size to reach statistical significance in the t-test. Assuming the effect size to be 0.6. Under the condition that α error is defined as 0.05; power was defined as 0.8; and the allocation ratio was defined as 1. Therefore, the sample size required to achieve statistical significance is 90 patients. The data used for the study will be preserved and analyzed by the primary investigator. The data is accessible only to the primary investigator and study nurse for data safety. The data will be preserved for 2 years after the end of the study.
- Conditions
- Arteriovenous Fistula
- Keywords
- arteriovenous fistula maturation, End stage renal disease, luminal pressure
- Medical subject headings
- Arteriovenous Fistula, Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study is spontaneous AVF maturation.
Spontaneous AVF maturation, which is defined as successful AVF puncture in hemodialysis for 6 consecutive sessions without any interventional procedure within 2 months.
Measured: 2 months
Secondary outcomes (1)
The secondary outcome is assisted AVF mature.
Assisted AVF maturation, which is defined as successful AVF puncture in hemodialysis for 6 consecutive sessions with any interventional procedure within 2 months.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start19 Sep 2018
- Primary completion7 May 2020 (estimated)
- Study completion7 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung-te Liu, MD, Study director, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017806
- Sponsor's protocol ID
- N201801091
- Status last verified
- Sep 2018
- First submitted
- 23 Apr 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bo S, Cavallo-Perin P, Gentile L, Repetti E, Pagano G. Hypouricemia and hyperuricemia in type 2 diabetes: two different phenotypes. Eur J Clin Invest. 2001 Apr;31(4):318-21. doi: 10.1046/j.1365-2362.2001.00812.x.
PubMed 11298778Edvardsson VO, Kaiser BA, Polinsky MS, Palmer JA, Quien R, Baluarte HJ. Natural history and etiology of hyperuricemia following pediatric renal transplantation. Pediatr Nephrol. 1995 Feb;9(1):57-60. doi: 10.1007/BF00858973.
PubMed 7742224Chonchol M, Shlipak MG, Katz R, Sarnak MJ, Newman AB, Siscovick DS, Kestenbaum B, Carney JK, Fried LF. Relationship of uric acid with progression of kidney disease. Am J Kidney Dis. 2007 Aug;50(2):239-47. doi: 10.1053/j.ajkd.2007.05.013.
PubMed 17660025Bellomo G, Venanzi S, Verdura C, Saronio P, Esposito A, Timio M. Association of uric acid with change in kidney function in healthy normotensive individuals. Am J Kidney Dis. 2010 Aug;56(2):264-72. doi: 10.1053/j.ajkd.2010.01.019. Epub 2010 Apr 10.
PubMed 20385436Sonoda H, Takase H, Dohi Y, Kimura G. Uric acid levels predict future development of chronic kidney disease. Am J Nephrol. 2011;33(4):352-7. doi: 10.1159/000326848. Epub 2011 Mar 25.
PubMed 21430373Iseki K, Oshiro S, Tozawa M, Iseki C, Ikemiya Y, Takishita S. Significance of hyperuricemia on the early detection of renal failure in a cohort of screened subjects. Hypertens Res. 2001 Nov;24(6):691-7. doi: 10.1291/hypres.24.691.
PubMed 11768729Kang DH, Nakagawa T, Feng L, Watanabe S, Han L, Mazzali M, Truong L, Harris R, Johnson RJ. A role for uric acid in the progression of renal disease. J Am Soc Nephrol. 2002 Dec;13(12):2888-97. doi: 10.1097/01.asn.0000034910.58454.fd.
PubMed 12444207Anker SD, Doehner W, Rauchhaus M, Sharma R, Francis D, Knosalla C, Davos CH, Cicoira M, Shamim W, Kemp M, Segal R, Osterziel KJ, Leyva F, Hetzer R, Ponikowski P, Coats AJ. Uric acid and survival in chronic heart failure: validation and application in metabolic, functional, and hemodynamic staging. Circulation. 2003 Apr 22;107(15):1991-7. doi: 10.1161/01.CIR.0000065637.10517.A0. Epub 2003 Apr 21.
PubMed 12707250Hsu SP, Pai MF, Peng YS, Chiang CK, Ho TI, Hung KY. Serum uric acid levels show a 'J-shaped' association with all-cause mortality in haemodialysis patients. Nephrol Dial Transplant. 2004 Feb;19(2):457-62. doi: 10.1093/ndt/gfg563.
PubMed 14736974Suliman ME, Johnson RJ, Garcia-Lopez E, Qureshi AR, Molinaei H, Carrero JJ, Heimburger O, Barany P, Axelsson J, Lindholm B, Stenvinkel P. J-shaped mortality relationship for uric acid in CKD. Am J Kidney Dis. 2006 Nov;48(5):761-71. doi: 10.1053/j.ajkd.2006.08.019.
PubMed 17059995Siu YP, Leung KT, Tong MK, Kwan TH. Use of allopurinol in slowing the progression of renal disease through its ability to lower serum uric acid level. Am J Kidney Dis. 2006 Jan;47(1):51-9. doi: 10.1053/j.ajkd.2005.10.006.
PubMed 16377385Goicoechea M, de Vinuesa SG, Verdalles U, Ruiz-Caro C, Ampuero J, Rincon A, Arroyo D, Luno J. Effect of allopurinol in chronic kidney disease progression and cardiovascular risk. Clin J Am Soc Nephrol. 2010 Aug;5(8):1388-93. doi: 10.2215/CJN.01580210. Epub 2010 Jun 10.
PubMed 20538833Wang H, Wei Y, Kong X, Xu D. Effects of urate-lowering therapy in hyperuricemia on slowing the progression of renal function: a meta-analysis. J Ren Nutr. 2013 Sep;23(5):389-96. doi: 10.1053/j.jrn.2012.08.005. Epub 2012 Nov 4.
PubMed 23131573Levy G, Cheetham TC. Is It Time to Start Treating Asymptomatic Hyperuricemia? Am J Kidney Dis. 2015 Dec;66(6):933-5. doi: 10.1053/j.ajkd.2015.09.002. No abstract available.
PubMed 26593311Hande KR, Noone RM, Stone WJ. Severe allopurinol toxicity. Description and guidelines for prevention in patients with renal insufficiency. Am J Med. 1984 Jan;76(1):47-56. doi: 10.1016/0002-9343(84)90743-5.
PubMed 6691361
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol for a Prospective Observational Study Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation
- ClinicalTrials.gov ID
- NCT04017806
- Acronym / sponsor ID
- N201801091
- Conditions
- Arteriovenous Fistula
- Keywords
- arteriovenous fistula maturation, End stage renal disease, luminal pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 7 May 2020 (estimated)
- Study completion
- 7 May 2020 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction Arteriovenous fistula (AVF) is the preferred hemodialysis vascular access due to its higher patency and lower infection rate. However, its major weakness is suboptimal maturation rate. Although that substantial risk factors for AVF maturation failure have been disclosed, a modifiable risk factor remains absent. While contemporary theory for AVF maturation failure focuses on disturbed wall shear stress, complicate assumtions and measurement preclude its clinical applicability. In the process of AVF maturation, elevated luminal pressure is required for outward remodeling, however, exccessively high luminal pressure may also be ditremental to AVF maturation, which remains to be defined. This study hypothesize that higher AVF luminal pressure is harmful to its maturation and investigate its potential as a modifiable factor to improve AVF maturation.
Methods and analysis This prospective study includes patients receiving surgical creation of native AVF. The exclusion criteria include age <20 years, inability to sign inform consent and failure to create native AVF deu to technical difficulty. Demographic and labboratory profile will be collected before AVF surgery. Vascular sonography will be performed within 1 week of AVF creation to measure the blood flow rates and diameters of AVF and its branched veins. The pressure gredient within AVF will be estimated from blood flow rates by Modified Bernoulli Equation. The primary outcome was spontaneous AVF maturation defined as provision of sufficient blood flow for hemodialysis within 2 months of its creation without any interventional procedures. The secondary outcome is assisted AVF mature, which is defined as AVF maturation within 2 months from its creation, which is aided by any interventional procedure before successful use of AVF.
Ethics and dissemination This study has been approved by the ethics committee and Institutional Review Board of Taipei Medical University.
Strengths and limitations
- The strength of the present study is the prospective design that allows complete collection of parameters and outcomes.
- The predictor of interest for AVF maturation is luminal pressure of AVF.
- The study assesses hemodynamic parameters of AVF and its branched veins, including diameters, flow rates, and flow volume.
- The luminal pressure of AVF will be estimated using Modified Bernoulli Equation.
- The primary outcome of the study is spontaneous AVF maturation.
Detailed description
Background: AVF is the preferred vascular access for maintenance hemodialysis. However, AVF is not an ideal vascular access without any drawback. Previous studies had revealed several risk factors of AVF maturation failure, including anemia, diabetes mellitus, and smoking. On the other hand, basic studies have revealed molecular pathogenic factors of AVF maturation failure, including localized inflammation, hypoxic injury, oscillating wall shear stress, uremic milieu and oxidative stress. Despite of these substantial studies exploring the role of pathogenic factors, a modifiable pathogenic factor that is applicable to improve AVF maturation remains lacking.
Maturation failure of AVF results from luminal stenosis due to neointimal hyperplasia, signifying thickening of subintimal area caused by proliferation of myofibroblast, which is remarkably stained for α-smooth muscle actin and vimentin. Neointimal hyperplasia of AVF occurs mainly at the arteriovenous junction and venous limb of AVF, where venous endothelium is exposed to non-physiologically high blood flow rate, oscillatory shear stress and pulsatile stretching strain by arterial blood flow, suggesting the role of altered hemodynamics on AVF subintimal proliferation. It has also been reported that endothelial cells from arterial and venous parts of circulation system show different genetic expression, indicating that different hemodynamic environment regulates phenotypes of endothelial cells. Therefore, it is reasonable that elevated luminal pressure may stimulate proliferation in venous endothelium of AVF and result in maturation failure. In contrast, elevated AVF luminal pressure also provides stretching force for outward remodeling, which is required for AVF maturation. Therefore, this prospective observational study is conducted to investigate the optimal AVF luminal pressure for AVF maturation, which may be modified surgically or pharmaceutically to improve AVF maturation rate.
Specific aims Aim 1: To characterize the altered blood flow rates and luminal pressures in different segments of AVF. Aim 2: To characterize the association between luminal pressures and vessel diameters of different segments of AVF. Aim 3: To investigate the association between AVF luminal pressure and AVF maturation rate. Aim 4: To investigate the association between AVF luminal pressure and known risk factors of AVF maturation failure.
Methods and analysis: This prospective observational study is mainly aimed to investigate the association between AVF luminal pressure and maturation rate. Patients who meet the following eligibility criteria are eligible for enrollment: (1) Patient at pre-dialysis or post-dialysis status who undergoes surgical creation of native AVF for hemodialysis will be included. (2) AVF created at both radial and brachial arteries are eligible for inclusion. Exclusion criteria: (1) Patients at age <20 years old will be excluded (2) Patients who are unconscious or unable to sign the inform consent will be excluded (3) Patient in whom native AVF creation is shifted to arteriovenous graft placement due to technical difficulty will be excluded from this study. The recruit of participants, collection of parameters, and confirmation of the outcomes are performed by a full-time study nurse.
Statistic methods: Continuous variables will be expressed as mean ± standard deviation, while nominal variables are expressed in frequency and percentage. Comparisons of continuous variables will be performed using the two-tailed t-test for unpaired samples or Welch's t-test as appropriate. Comparisons of nominal variables will be performed using the Chi-square test or Fisher's exact test as appropriate. Multivariate logistic regression test will be used to evaluate the association between predictor variables and outcome variables. Statistical significance will be defined by a P value of <0.05. The statistics will be performed using SAS 9.4 (SAS Institute Inc, Cary, NC, USA). G*Power 3.1.9.4 was used to estimate the sample size to reach statistical significance in the t-test. Assuming the effect size to be 0.6. Under the condition that α error is defined as 0.05; power was defined as 0.8; and the allocation ratio was defined as 1. Therefore, the sample size required to achieve statistical significance is 90 patients. The data used for the study will be preserved and analyzed by the primary investigator. The data is accessible only to the primary investigator and study nurse for data safety. The data will be preserved for 2 years after the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who receives surgical anastomosis of hemodialysis AVF will be included, whether the patient is a pre-dialysis patient, fresh uremic patient or who already on dialysis treatment.
Key inclusion criteria (2 listed)
- Patients with hemodialysis who receiving AVF.
- AVF created at both radial and brachial arteries
Key exclusion criteria (3 listed)
- Patients at age <20 years old
- Patients who are unconscious or unable to sign the inform consent
- Patient in whom native AVF creation is shifted to arteriovenous graft placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome of this study is spontaneous AVF maturation.
Time frame: 2 months
Spontaneous AVF maturation, which is defined as successful AVF puncture in hemodialysis for 6 consecutive sessions without any interventional procedure within 2 months.
1 secondary outcome
The secondary outcome is assisted AVF mature.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 11298778Bo S, Cavallo-Perin P, Gentile L, Repetti E, Pagano G. Hypouricemia and hyperuricemia in type 2 diabetes: two different phenotypes. Eur J Clin Invest. 2001 Apr;31(4):318-21. doi: 10.1046/j.1365-2362.2001.00812.x.
- Background: PubMed 7742224Edvardsson VO, Kaiser BA, Polinsky MS, Palmer JA, Quien R, Baluarte HJ. Natural history and etiology of hyperuricemia following pediatric renal transplantation. Pediatr Nephrol. 1995 Feb;9(1):57-60. doi: 10.1007/BF00858973.
- Background: PubMed 17660025Chonchol M, Shlipak MG, Katz R, Sarnak MJ, Newman AB, Siscovick DS, Kestenbaum B, Carney JK, Fried LF. Relationship of uric acid with progression of kidney disease. Am J Kidney Dis. 2007 Aug;50(2):239-47. doi: 10.1053/j.ajkd.2007.05.013.
- Background: PubMed 20385436Bellomo G, Venanzi S, Verdura C, Saronio P, Esposito A, Timio M. Association of uric acid with change in kidney function in healthy normotensive individuals. Am J Kidney Dis. 2010 Aug;56(2):264-72. doi: 10.1053/j.ajkd.2010.01.019. Epub 2010 Apr 10.
- Background: PubMed 21430373Sonoda H, Takase H, Dohi Y, Kimura G. Uric acid levels predict future development of chronic kidney disease. Am J Nephrol. 2011;33(4):352-7. doi: 10.1159/000326848. Epub 2011 Mar 25.
- Background: PubMed 11768729Iseki K, Oshiro S, Tozawa M, Iseki C, Ikemiya Y, Takishita S. Significance of hyperuricemia on the early detection of renal failure in a cohort of screened subjects. Hypertens Res. 2001 Nov;24(6):691-7. doi: 10.1291/hypres.24.691.
- Background: PubMed 12444207Kang DH, Nakagawa T, Feng L, Watanabe S, Han L, Mazzali M, Truong L, Harris R, Johnson RJ. A role for uric acid in the progression of renal disease. J Am Soc Nephrol. 2002 Dec;13(12):2888-97. doi: 10.1097/01.asn.0000034910.58454.fd.
- Background: PubMed 12707250Anker SD, Doehner W, Rauchhaus M, Sharma R, Francis D, Knosalla C, Davos CH, Cicoira M, Shamim W, Kemp M, Segal R, Osterziel KJ, Leyva F, Hetzer R, Ponikowski P, Coats AJ. Uric acid and survival in chronic heart failure: validation and application in metabolic, functional, and hemodynamic staging. Circulation. 2003 Apr 22;107(15):1991-7. doi: 10.1161/01.CIR.0000065637.10517.A0. Epub 2003 Apr 21.
- Background: PubMed 14736974Hsu SP, Pai MF, Peng YS, Chiang CK, Ho TI, Hung KY. Serum uric acid levels show a 'J-shaped' association with all-cause mortality in haemodialysis patients. Nephrol Dial Transplant. 2004 Feb;19(2):457-62. doi: 10.1093/ndt/gfg563.
- Background: PubMed 17059995Suliman ME, Johnson RJ, Garcia-Lopez E, Qureshi AR, Molinaei H, Carrero JJ, Heimburger O, Barany P, Axelsson J, Lindholm B, Stenvinkel P. J-shaped mortality relationship for uric acid in CKD. Am J Kidney Dis. 2006 Nov;48(5):761-71. doi: 10.1053/j.ajkd.2006.08.019.
- Background: PubMed 16377385Siu YP, Leung KT, Tong MK, Kwan TH. Use of allopurinol in slowing the progression of renal disease through its ability to lower serum uric acid level. Am J Kidney Dis. 2006 Jan;47(1):51-9. doi: 10.1053/j.ajkd.2005.10.006.
- Background: PubMed 20538833Goicoechea M, de Vinuesa SG, Verdalles U, Ruiz-Caro C, Ampuero J, Rincon A, Arroyo D, Luno J. Effect of allopurinol in chronic kidney disease progression and cardiovascular risk. Clin J Am Soc Nephrol. 2010 Aug;5(8):1388-93. doi: 10.2215/CJN.01580210. Epub 2010 Jun 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-te Liu, MD study director
Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung-te Liu, MD (886-970746583, 96320@wtmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of this study is spontaneous AVF maturation. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04017806, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.