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Approach to Vascular Access After Renal Transplantation (AVART)

W

Wroclaw Medical University

Status

Unknown

Conditions

Kidney Transplantation

Treatments

Other: presence of AVF

Study type

Observational

Funder types

Other

Identifiers

NCT04478968
MINI.C160.20.001

Details and patient eligibility

About

The aim of the project is to assess the effect of functioning AVF in renal transplant patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75 patients with inactive vascular access. We will assess the impact of functional AVF and the levels of biomarkers on the survival of patients and transplanted kidneys.

Full description

Patients after kidney transplantation during a routine visit will be asked to participate to the study. In eligible a number of studies will be conducted:

  • detailed clinical examination
  • routine laboratory tests
  • lung ultrasound
  • muscle strength with a dynamometer
  • ultrasound assessment of upper limb vessels with assessment of fistula function (in the case of active fistula) and for the possibility of future vascular access
  • blood collection and protection (10-15 ml) for biomarkers
  • survey EQ-5D-5L and LVD-36
  • functional strength test.

The obtained clinical data and test results will be subject to statistical analysis after anonymization. The impact of individual parameters on long-term prognosis will be assessed.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age> 18 years old
  • kidney transplant
  • >12 months after transplantation
  • stable transplanted kidney function
  • signed informed consent

Exclusion criteria

  • GFR <15 ml / min
  • severe infection within 3 months of testing
  • increase in creatinine concentration> 0.5 mg / dl within 3 months before the test
  • active cancer
  • signs of severe heart failure (NYHA IV)

Trial design

150 participants in 2 patient groups

Active AVF
Description:
Patients after kidney transplantation with functioning AVF
Treatment:
Other: presence of AVF
No AVF
Description:
Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation)

Trial contacts and locations

1

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Central trial contact

Krzysztof Letachowicz, MD, PhD

Data sourced from clinicaltrials.gov

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