Assessment of Volumetric Hemodynamic Parameters and Nutritional Status in Stable Renal Transplant Recipients

September 12, 2016 updated by: Łukasz Czyżewski, Medical University of Warsaw
Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. Ilmenau) in stable renal transplant recipients Nutritional status was measured by Tanita 418 Monitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

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

No

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients after kidney transplantation
The study included who had been admitted to a nephrology-transplantation outpatient clinic 0.5 to 30 years after kidney transplantation.
Device: CardioScreen 1000
Haemodynamic Measurement System, Medis Impedance cardiography (ICG)
Device: Tanita 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).
Healthy subjects
Medical staff: medical doctors, nurses
Device: CardioScreen 1000
Haemodynamic Measurement System, Medis Impedance cardiography (ICG)
Device: Tanita 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of cardiac index in Stable Renal Transplant Recipients
Time Frame: 1 day
Measurement of cardiac index (l/min/m2)
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Nutritional Status in Stable Renal Transplant Recipients
Time Frame: 1 day
Measurement of amount of fat tissue (%)
1 day
Assessment of Systemic Vascular Resistance Index in Stable Renal Transplant Recipients
Time Frame: 1 day
Measurement of Systemic Vascular Resistance Index (dynes-sec/cm-5/m2)
1 day

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

July 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.I/KTx/2016/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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