Uremia; ChronicNCT06249373

The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF

A study testing Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis in people with Uremia; Chronic, run by Suzhou Municipal Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Uremia; Chronic
What is being tested?: Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteChina
Study dates: 26 Feb 2024to 31 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1.18 years old ≤ Age ≤ 75 years old, regardless of gender or ethnicity;
2.Dialysis or non-dialysis patients who have newly established autologous arteriovenous fistula in the wrist and have not yet used the fistula for hemodialysis treatment;
3.Before establishing an autologous arteriovenous fistula in the wrist, ultrasound examination will be performed. The radial artery diameter at the intended surgical site is>1.5mm, and the head vein diameter is>2mm （using a tourniquet）. The arterial and venous blood flow are unobstructed, and the distance between the vein and the skin is<6mm;
4. After introducing dialysis, the calcium ion concentration in the dialysate will be maintained at 1.5mmol/L during the dialysis period, and low molecular weight heparin will be used for anticoagulation. The dosage of low molecular weight heparin remains unchanged （±1000U） during the study period;
5. Sign an informed consent form.

Who cannot join

Poor healing of internal fistula surgical incision;
Active bacterial or viral infections;
Pregnant women;
The patient underwent kidney transplantation or was transferred to peritoneal dialysis during the study period;
Subject ALT, AST ≥ 3 × upper limit of normal values;
Within 3 months, according to NYHA classification, heart function is classified as level III-IV;

Show all 12Show fewer

Newly diagnosed unstable angina and cerebrovascular events within 3 months;
Blood pressure below 90/60mmHg or above 180/100mmHg in the past 2 weeks;
During the study period, patients did not follow medical advice and arbitrarily changed the types and dosages of other anticoagulants or anticoagulants (such as aspirin, clopidogrel, Agat Roban, etc.);
Combine the use of glucocorticoids and immunosuppressants, such as tacrolimus, cyclosporine, MMF, azathioprine, leflunomide, Tripterygium wilfordii glycosides, etc;
Other researchers consider inappropriate situations, such as coexisting with malignant tumors, where the expected lifespan is less than 6 months;
I have participated in other clinical trials within 4 weeks prior to the start of this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qiang Chen contact

+8618901547679

chenqjs@126.com

China1 site, 1 recruiting

The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital
Suzhou, Jiangsu
Chen Qiang, 18901547679, chenqjs@126.com
Recruiting

Other trials in China

About this study

Official title: A Multicenter Randomized Controlled Trial on the Effect of Low-intensity Pulsed Ultrasound on the Maturation of Newly Constructed Autogenous Arteriovenous Fistulas in Uremic Patients

This study aims to evaluate the effect of 12 week low-intensity pulse ultrasound (LIPUS) intervention on the maturation of newly constructed autologous arteriovenous fistulas in uremic patients. This study is a prospective, blinded, randomized controlled trial. This trial is divided into two stages. The first stage is a concept validation trial, which is a single center, prospective, blinded, randomized controlled clinical study. Subjects who meet the screening criteria are randomly divided into an intervention group and a control group in a 1:1 ratio. All subjects underwent safety and efficacy evaluations at the 2nd, 4th, 8th, 12th, and 4th week after treatment. After completing a 4-week follow-up of the 20th study subject, an analysis was conducted with the preset goal of achieving a higher maturation rate of arteriovenous fistula in the intervention group compared to the control group at the follow-up point, and the safety of the study was evaluated. The second stage is a key trial, which is a multicenter, prospective, blinded, randomized controlled clinical study. The inclusion criteria, primary and secondary endpoints, and safety endpoints of the study subjects remain unchanged, and the safety and efficacy of the overall population are evaluated.

Conditions: Uremia; Chronic
Being tested: Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis
Medical subject headings: Uremia, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosisDevice
The LIPUS intervention group for arteriovenous fistula should receive forearm wearable portable low-intensity pulse ultrasound （LIPUS） intervention at the anastomotic site no more than 3 days after suture removal two weeks after the fistula surgery. If the ultrasound examination indicates the presence of stenosis in the outflow tract, the intervention should also be performed at the same time. It belongs to non-invasive extracorporeal intervention, with three times a week （during dialysis） for 20 minutes each time. The sound intensity is 350mW/cm2, the pulse frequency is 1MHz, the pulse repetition frequency is 100Hz, the pulse frequency is 100 times, and the treatment period is 12 weeks.

Study groups in NCT06249373
Study group	Role	What they receive
LIPUS intervention group	Experimental	Low intensity pulse ultrasound （LIPUS） intervenes at the anastomotic site, and if the ultrasound examination indicates the presence of a narrow site in the outflow tract, it also intervenes at the narrow site. It belongs to non-invasive extracorporeal intervention, with three times a week （during dialysis） for 20 minutes each time. The sound intensity is 350mW/cm2, the pulse frequency is 1MHz, the pulse repetition frequency is 100Hz, the pulse frequency is 100 times, and the treatment period is 12 weeks. Receives: Device: Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis
Simulated LIPUS control group	No intervention	Using the same forearm wearable portable ultrasound as the LIPUS arteriovenous fistula intervention group, but not issuing low-intensity pulse ultrasound.

What is being measured

The primary outcome is the main question the study is designed to answer.

Maturity rate of arteriovenous fistula
Puncture segment venous diameter
Measured: 12 weeks after enrollment
Maturity rate of arteriovenous fistula
Brachial artery blood flow rate
Measured: 12 weeks after enrollment

Secondary outcomes (4)

Changes in hemodynamic parameters
Blood flow
Measured: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Minimum outflow venous diameter
Measured: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Primary patency rate
Measured: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Secondary patency rate
Measured: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 202431 Dec 2026

First posted8 Feb 2024
Study start26 Feb 2024
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Uremia; ChronicStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06249373
Sponsor's protocol ID: K-2023-094
Status last verified: May 2024
First submitted: 29 Jan 2024
Last updated: 16 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Nunes NS, Chandran P, Sundby M, Visioli F, da Costa Goncalves F, Burks SR, Paz AH, Frank JA. Therapeutic ultrasound attenuates DSS-induced colitis through the cholinergic anti-inflammatory pathway. EBioMedicine. 2019 Jul;45:495-510. doi: 10.1016/j.ebiom.2019.06.033. Epub 2019 Jun 26.
PubMed 31253515
Salmela B, Hartman J, Peltonen S, Alback A, Lassila R. Thrombophilia and arteriovenous fistula survival in ESRD. Clin J Am Soc Nephrol. 2013 Jun;8(6):962-8. doi: 10.2215/CJN.03860412. Epub 2013 Feb 14.
PubMed 23411429
Sifuentes-Franco S, Padilla-Tejeda DE, Carrillo-Ibarra S, Miranda-Diaz AG. Oxidative Stress, Apoptosis, and Mitochondrial Function in Diabetic Nephropathy. Int J Endocrinol. 2018 Apr 1;2018:1875870. doi: 10.1155/2018/1875870. eCollection 2018.
PubMed 29808088
Masengu A, McDaid J, Maxwell AP, Hanko JB. Preoperative radial artery volume flow is predictive of arteriovenous fistula outcomes. J Vasc Surg. 2016 Feb;63(2):429-35. doi: 10.1016/j.jvs.2015.08.106.
PubMed 26804217
Riella MC, Roy-Chaudhury P. Vascular access in haemodialysis: strengthening the Achilles' heel. Nat Rev Nephrol. 2013 Jun;9(6):348-57. doi: 10.1038/nrneph.2013.76. Epub 2013 Apr 16.
PubMed 23591442
Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.
PubMed 24183112
Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
PubMed 18477783
Irish AB, Viecelli AK, Hawley CM, Hooi LS, Pascoe EM, Paul-Brent PA, Badve SV, Mori TA, Cass A, Kerr PG, Voss D, Ong LM, Polkinghorne KR; Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) Study Collaborative Group. Effect of Fish Oil Supplementation and Aspirin Use on Arteriovenous Fistula Failure in Patients Requiring Hemodialysis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 1;177(2):184-193. doi: 10.1001/jamainternmed.2016.8029.
PubMed 28055065
Remuzzi A, Bozzetto M, Brambilla P. Is shear stress the key factor for AVF maturation? J Vasc Access. 2017 Mar 6;18(Suppl. 1):10-14. doi: 10.5301/jva.5000686. Epub 2017 Mar 5.
PubMed 28297046
Dolan JM, Kolega J, Meng H. High wall shear stress and spatial gradients in vascular pathology: a review. Ann Biomed Eng. 2013 Jul;41(7):1411-27. doi: 10.1007/s10439-012-0695-0. Epub 2012 Dec 11.
PubMed 23229281
Kaygin MA, Halici U, Aydin A, Dag O, Binici DN, Limandal HK, Arslan U, Kiymaz A, Kahraman N, Calik ES, Savur AI, Erkut B. The relationship between arteriovenous fistula success and inflammation. Ren Fail. 2013 Sep;35(8):1085-8. doi: 10.3109/0886022X.2013.815100. Epub 2013 Aug 1.
PubMed 23906289
Asare Y, Schmitt M, Bernhagen J. The vascular biology of macrophage migration inhibitory factor (MIF). Expression and effects in inflammation, atherogenesis and angiogenesis. Thromb Haemost. 2013 Mar;109(3):391-8. doi: 10.1160/TH12-11-0831. Epub 2013 Jan 17.
PubMed 23329140
Stangenberg S, Nguyen LT, Chen H, Al-Odat I, Killingsworth MC, Gosnell ME, Anwer AG, Goldys EM, Pollock CA, Saad S. Oxidative stress, mitochondrial perturbations and fetal programming of renal disease induced by maternal smoking. Int J Biochem Cell Biol. 2015 Jul;64:81-90. doi: 10.1016/j.biocel.2015.03.017. Epub 2015 Apr 4.
PubMed 25849459
Yang B, Janardhanan R, Vohra P, Greene EL, Bhattacharya S, Withers S, Roy B, Nieves Torres EC, Mandrekar J, Leof EB, Mukhopadhyay D, Misra S. Adventitial transduction of lentivirus-shRNA-VEGF-A in arteriovenous fistula reduces venous stenosis formation. Kidney Int. 2014 Feb;85(2):289-306. doi: 10.1038/ki.2013.290. Epub 2013 Aug 7.
PubMed 23924957
Veillat V, Carli C, Metz CN, Al-Abed Y, Naccache PH, Akoum A. Macrophage migration inhibitory factor elicits an angiogenic phenotype in human ectopic endometrial cells and triggers the production of major angiogenic factors via CD44, CD74, and MAPK signaling pathways. J Clin Endocrinol Metab. 2010 Dec;95(12):E403-12. doi: 10.1210/jc.2010-0417. Epub 2010 Sep 8.
PubMed 20829186

Interested in taking part?

Qiang Chen

+8618901547679

chenqjs@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Uremia; Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Randomized Controlled Trial on the Effect of Low-intensity Pulsed Ultrasound on the Maturation of Newly Constructed Autogenous Arteriovenous Fistulas in Uremic Patients
ClinicalTrials.gov ID: NCT06249373
Acronym / sponsor ID: K-2023-094
Conditions: Uremia; Chronic
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: Suzhou Municipal HospitalUniversity, hospital or other
Collaborators: The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Soochow University, Second Affiliated Hospital of Soochow University, Dushu Lake Hospital Affiliated to Soochow University
Study start: 26 Feb 2024 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 8 Feb 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LIPUS intervention group	Experimental	Device: Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosisLow intensity pulse ultrasound （LIPUS） intervenes at the anastomotic site, and if the ultrasound examination indicates the presence of a narrow site in the outflow tract, it also intervenes at the narrow site. It belongs to non-invasive extracorporeal intervention, with three times a week （during dialysis） for 20 minutes each time. The sound intensity is 350mW/cm2, the pulse frequency is 1MHz, the pulse repetition frequency is 100Hz, the pulse frequency is 100 times, and the treatment period is 12 weeks.
Simulated LIPUS control group	No intervention	–Using the same forearm wearable portable ultrasound as the LIPUS arteriovenous fistula intervention group, but not issuing low-intensity pulse ultrasound.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

1.18 years old ≤ Age ≤ 75 years old, regardless of gender or ethnicity;
2.Dialysis or non-dialysis patients who have newly established autologous arteriovenous fistula in the wrist and have not yet used the fistula for hemodialysis treatment;
3.Before establishing an autologous arteriovenous fistula in the wrist, ultrasound examination will be performed. The radial artery diameter at the intended surgical site is>1.5mm, and the head vein diameter is>2mm （using a tourniquet）. The arterial and venous blood flow are unobstructed, and the distance between the vein and the skin is<6mm;
4. After introducing dialysis, the calcium ion concentration in the dialysate will be maintained at 1.5mmol/L during the dialysis period, and low molecular weight heparin will be used for anticoagulation. The dosage of low molecular weight heparin remains unchanged （±1000U） during the study period;
5. Sign an informed consent form.

Key exclusion criteria (12 listed)

Poor healing of internal fistula surgical incision;
Active bacterial or viral infections;
Pregnant women;
The patient underwent kidney transplantation or was transferred to peritoneal dialysis during the study period;
Subject ALT, AST ≥ 3 × upper limit of normal values;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosisThe LIPUS intervention group for arteriovenous fistula should receive forearm wearable portable low-intensity pulse ultrasound （LIPUS） intervention at the anastomotic site no more than 3 days after suture removal two weeks after the fistula surgery. If the ultrasound examination indicates the presence of stenosis in the outflow tract, the intervention should also be performed at the same time. It belongs to non-invasive extracorporeal intervention, with three times a week （during dialysis） for 20 minutes each time. The sound intensity is 350mW/cm2, the pulse frequency is 1MHz, the pulse repetition frequency is 100Hz, the pulse frequency is 100 times, and the treatment period is 12 weeks.	Device	LIPUS intervention group

Primary outcome

Maturity rate of arteriovenous fistula
Time frame: 12 weeks after enrollment
Puncture segment venous diameter
Maturity rate of arteriovenous fistula
Time frame: 12 weeks after enrollment
Brachial artery blood flow rate

4 secondary outcomes

Changes in hemodynamic parameters
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Background: PubMed 31253515Nunes NS, Chandran P, Sundby M, Visioli F, da Costa Goncalves F, Burks SR, Paz AH, Frank JA. Therapeutic ultrasound attenuates DSS-induced colitis through the cholinergic anti-inflammatory pathway. EBioMedicine. 2019 Jul;45:495-510. doi: 10.1016/j.ebiom.2019.06.033. Epub 2019 Jun 26.
Background: PubMed 23411429Salmela B, Hartman J, Peltonen S, Alback A, Lassila R. Thrombophilia and arteriovenous fistula survival in ESRD. Clin J Am Soc Nephrol. 2013 Jun;8(6):962-8. doi: 10.2215/CJN.03860412. Epub 2013 Feb 14.
Background: PubMed 29808088Sifuentes-Franco S, Padilla-Tejeda DE, Carrillo-Ibarra S, Miranda-Diaz AG. Oxidative Stress, Apoptosis, and Mitochondrial Function in Diabetic Nephropathy. Int J Endocrinol. 2018 Apr 1;2018:1875870. doi: 10.1155/2018/1875870. eCollection 2018.
Background: PubMed 26804217Masengu A, McDaid J, Maxwell AP, Hanko JB. Preoperative radial artery volume flow is predictive of arteriovenous fistula outcomes. J Vasc Surg. 2016 Feb;63(2):429-35. doi: 10.1016/j.jvs.2015.08.106.
Background: PubMed 23591442Riella MC, Roy-Chaudhury P. Vascular access in haemodialysis: strengthening the Achilles' heel. Nat Rev Nephrol. 2013 Jun;9(6):348-57. doi: 10.1038/nrneph.2013.76. Epub 2013 Apr 16.
Background: PubMed 24183112Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.
Background: PubMed 18477783Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.
Background: PubMed 28055065Irish AB, Viecelli AK, Hawley CM, Hooi LS, Pascoe EM, Paul-Brent PA, Badve SV, Mori TA, Cass A, Kerr PG, Voss D, Ong LM, Polkinghorne KR; Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) Study Collaborative Group. Effect of Fish Oil Supplementation and Aspirin Use on Arteriovenous Fistula Failure in Patients Requiring Hemodialysis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 1;177(2):184-193. doi: 10.1001/jamainternmed.2016.8029.
Background: PubMed 28297046Remuzzi A, Bozzetto M, Brambilla P. Is shear stress the key factor for AVF maturation? J Vasc Access. 2017 Mar 6;18(Suppl. 1):10-14. doi: 10.5301/jva.5000686. Epub 2017 Mar 5.
Background: PubMed 23229281Dolan JM, Kolega J, Meng H. High wall shear stress and spatial gradients in vascular pathology: a review. Ann Biomed Eng. 2013 Jul;41(7):1411-27. doi: 10.1007/s10439-012-0695-0. Epub 2012 Dec 11.
Background: PubMed 23906289Kaygin MA, Halici U, Aydin A, Dag O, Binici DN, Limandal HK, Arslan U, Kiymaz A, Kahraman N, Calik ES, Savur AI, Erkut B. The relationship between arteriovenous fistula success and inflammation. Ren Fail. 2013 Sep;35(8):1085-8. doi: 10.3109/0886022X.2013.815100. Epub 2013 Aug 1.
Background: PubMed 23329140Asare Y, Schmitt M, Bernhagen J. The vascular biology of macrophage migration inhibitory factor (MIF). Expression and effects in inflammation, atherogenesis and angiogenesis. Thromb Haemost. 2013 Mar;109(3):391-8. doi: 10.1160/TH12-11-0831. Epub 2013 Jan 17.
Individual participant dataSharing planned: No

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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.

Qiang Chen contact

+8618901547679

chenqjs@126.com

Xiangqing Kong study chair

Suzhou Municipal Hospital

Huijuan Mao study director

The First Affiliated Hospital with Nanjing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis in people with Uremia; Chronic, run by Suzhou Municipal Hospital at 1 site in China.

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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 16 May 2024. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiang Chen (+8618901547679, chenqjs@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maturity rate of arteriovenous fistula (time frame: 12 weeks after enrollment). The study lists 2 primary outcomes in all. 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 NCT06249373, which also lists 25 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 16 May 2024.