Clinical trial NCT02852941: Assessment of Volumetric Hemodynamic Parameters and Nutritional Status in Stable Renal Transplant Recipients
Official title: Assessment of Volumetric Hemodynamic Parameters and Nutritional Status in Stable Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output, Low
High Blood Pressure
Keywords: Impedance
Kidney Transplantation
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of cardiac index in Stable Renal Transplant Recipients
timeFrame: 1 day
Secondary outcomes:
measure: Assessment of Nutritional Status in Stable Renal Transplant Recipients
timeFrame: 1 day
measure: Assessment of Systemic Vascular Resistance Index in Stable Renal Transplant Recipients
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
state: Mazovian
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.