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

High Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852941
• Other study ID #: C.I/KTx/2016/07
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: September 12, 2016
• Start date: July 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiac Output, Low
• High Blood Pressure
• Hypertension

Intervention

Device:
• CardioScreen 1000
Haemodynamic Measurement System, Medis Impedance cardiography (ICG)
• 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).

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of cardiac index in Stable Renal Transplant Recipients	Measurement of cardiac index (l/min/m2)	1 day	No
Secondary	Assessment of Nutritional Status in Stable Renal Transplant Recipients	Measurement of amount of fat tissue (%)	1 day	No
Secondary	Assessment of Systemic Vascular Resistance Index in Stable Renal Transplant Recipients	Measurement of Systemic Vascular Resistance Index (dynes-sec/cm-5/m2)	1 day	No