Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients

June 13, 2017 updated by: Łukasz Czyżewski, Medical University of Warsaw
Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device in perioperative time after kidney transplantation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

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
    • Mazowian
      • Warsaw, Mazowian, Poland, 02-091
        • Recruiting
        • Medical University of Warsaw
        • Contact:
        • Principal Investigator:
          • Lukasz Czyzewski, PhD
        • Sub-Investigator:
          • Janusz Wyzgal, Professor, MD
        • Sub-Investigator:
          • Emilia Czyzewska, MSc
        • Sub-Investigator:
          • Agnieszka Pacek, Student
        • Sub-Investigator:
          • Aleksandra Tomaszek, MSc
        • Sub-Investigator:
          • Lukasz Szarpak, PhD

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 40 consecutive patients admitted to Transplant Centre to perform kidney transplantataion were included in this study.

Description

Inclusion Criteria:

  • give voluntary consent to participate in the study
  • no clinical cardiovascular disease during the 6 months preceding entry

Exclusion Criteria:

  • not meet the above criteria

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients before kidney transplantation
The study included who had been admitted to the TransplantClinic before kidney transplantation
Device: BR-102 plus PWA
Monitoring of Arterial Stiffness and Central Aortic Pressure
Device: Tanita MC780 MA S
The device measured the size of total body water (TBW), Extra Cellular Water (ECW), Intra Cellular Water (ICW), fat mass (FM%), visceral fat%, fat free mass (FFM) and basal metabolic rate, (BMR) (kcal).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in pulse wave velocity [m/s] in short postoperative period.
Time Frame: 3 days (one day before kidney transplantation and two days after kidney transplantation)
Assessment will be performed one day before kidney transplantation and two days after kidney transplantation
3 days (one day before kidney transplantation and two days after kidney transplantation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in central aortic pressure [mmHg] in short postoperative period.
Time Frame: 3 days (one day before kidney transplantation and two days after kidney transplantation)
Assessment will be performed one day before kidney transplantation and two days after kidney transplantation
3 days (one day before kidney transplantation and two days after kidney transplantation)

Collaborators and Investigators

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

Sponsor

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

September 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PWV/KTx/2016/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Subscribe