Short and Long-term Results of Arterial Stiffness and Central Aortic Pressure After Kidney Transplantation (PWV/CP/KTx)

September 30, 2015 updated by: Łukasz Czyżewski, Medical University of Warsaw
Central blood pressure and pulse wave velocity were measured using a Complior Analyse device in Short and Long-term after kidney transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazovian
      • Warsaw, Mazovian, Poland, 02-091
        • Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 100 consecutive patients admitted to routine visin in Transplant Centre and 30 healthy subjects were included in this study.

Description

Inclusion Criteria:

  • give voluntary consent to participate in the study
  • functioning graft longer than 3 months to 10 years
  • no clinical cardiovascular disease during the 6 months preceding entry
  • stable graft function- glomerular filtration rate > 30 ml/min/1.73 m2, creatinine concentration <2.5 mg/dl
  • medical staff (medical doctors, nurses)

Exclusion Criteria:

  • not meet the above criteria
  • episode of illness (for example: infection)
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy subjects
Medical staff: medical doctors, nurses
Device: Device: Complior Analyse System
Monitoring of Arterial Stiffness and Central Aortic Pressure
Patients after kidney transplantation
Short and Long-term results containing first 10 years after KTx.
Device: Tanita BC 418- Bioelectrical impedance analysis
The device measured the size of total body water (TBW), fat mass (FM%), visceral fat%, fat free mass (FFM), and basal metabolic rate (BMR) (kcal).
Device: Device: Complior Analyse System
Monitoring of Arterial Stiffness and Central Aortic Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in carotid-femoral pulse wave velocity [m/s] in short and long-term postoperative period.
Time Frame: 1 day
Measurements will be performed in routine visits in Transplant Centre.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in central aortic pressure [mmHg] in short and long-term postoperative period.
Time Frame: 1 day
Measurements will be performed in routine visits in Transplant Centre.
1 day
Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] in short and long-term postoperative period.
Time Frame: 1 day
Measurements will be performed in routine visits in Transplant Centre.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Łukasz Czyżewski, PhD, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

May 10, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (ESTIMATE)

May 13, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PWV/CP/KTx/2015/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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