NCT02852941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

July 27, 2016

Last Update Submit

September 12, 2016

Conditions

Cardiac Output, LowHigh Blood Pressure

Keywords

ImpedanceKidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Assessment of cardiac index in Stable Renal Transplant Recipients

    Measurement of cardiac index (l/min/m2)

    1 day

Secondary Outcomes (2)

  • Assessment of Nutritional Status in Stable Renal Transplant Recipients

    1 day

  • Assessment of Systemic Vascular Resistance Index in Stable Renal Transplant Recipients

    1 day

Study Arms (2)

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 1000Device: Tanita 418- Bioelectrical impedance analysis

Healthy subjects

Medical staff: medical doctors, nurses

Device: CardioScreen 1000Device: Tanita 418- Bioelectrical impedance analysis

Interventions

CardioScreen 1000DEVICE

Haemodynamic Measurement System, Medis Impedance cardiography (ICG)

Healthy subjectsPatients after kidney transplantation
Tanita 418- Bioelectrical impedance analysisDEVICE

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 subjectsPatients after kidney transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw

Warsaw, Mazovian, 02-091, Poland

Location

Related Publications (4)

  • Czyzewski L, Wyzgal J, Czyzewska E, Kurowski A, Sierdzinski J, Truszewski Z, Szarpak L. Assessment of Arterial Stiffness, Volume, and Nutritional Status in Stable Renal Transplant Recipients. Medicine (Baltimore). 2016 Feb;95(6):e2819. doi: 10.1097/MD.0000000000002819.

    PMID: 26871855BACKGROUND

  • Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248.

    PMID: 25365639BACKGROUND

  • Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189.

    PMID: 24770703BACKGROUND

  • Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265.

    PMID: 25382249BACKGROUND

MeSH Terms

Conditions

Cardiac Output, LowHypertension

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 2, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)