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

Sponsor
Medical University of Warsaw (Other)
Overall Status
Completed
CT.gov ID
NCT02852941
Collaborator
(none)
80
1
1
78.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CardioScreen 1000
  • Device: Tanita 418- Bioelectrical impedance analysis

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Volumetric Hemodynamic Parameters and Nutritional Status in Stable Renal Transplant Recipients
Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Assessment of cardiac index in Stable Renal Transplant Recipients [1 day]

    Measurement of cardiac index (l/min/m2)

Secondary Outcome Measures

  1. Assessment of Nutritional Status in Stable Renal Transplant Recipients [1 day]

    Measurement of amount of fat tissue (%)

  2. Assessment of Systemic Vascular Resistance Index in Stable Renal Transplant Recipients [1 day]

    Measurement of Systemic Vascular Resistance Index (dynes-sec/cm-5/m2)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Warsaw Warsaw Mazovian Poland 02-091

Sponsors and Collaborators

  • Medical University of Warsaw

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Łukasz Czyżewski, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT02852941
Other Study ID Numbers:
  • C.I/KTx/2016/07
First Posted:
Aug 2, 2016
Last Update Posted:
Sep 13, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Łukasz Czyżewski, PhD, Medical University of Warsaw
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2016