Approach to Vascular Access After Renal Transplantation

NCT ID: NCT04478968

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-03

Study Completion Date

2022-01-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Active AVF

Patients after kidney transplantation with functioning AVF

presence of AVF

Intervention Type OTHER

Functioning AVF may have cardiotoxic potential

No AVF

Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation)

No interventions assigned to this group

Interventions

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presence of AVF

Functioning AVF may have cardiotoxic potential

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krzysztof Letachowicz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wroclaw Medical University

Locations

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Department of Nephrology and Transplantation Medicine

Wroclaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Krzysztof Letachowicz, MD, PhD

Role: CONTACT

+48717332546

Facility Contacts

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Krzysztof Letachowicz, MD, PhD

Role: primary

+48717332546

Other Identifiers

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MINI.C160.20.001

Identifier Type: -

Identifier Source: org_study_id

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