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NCT02908139 Clinical Trial

Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02908139
Other study ID # PWV/KTx/2016/09
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2016
Last updated June 13, 2017
Start date September 2016
Est. completion date September 2017

Study information
Verified date June 2017
Source Medical University of Warsaw
Contact Lukasz Czyzewski, PhD
Phone 696457655
Email czyzewski_lukasz@wp.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device in perioperative time after kidney transplantation

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- give voluntary consent to participate in the study

- no clinical cardiovascular disease during the 6 months preceding entry

Exclusion Criteria:

- not meet the above criteria

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• BR-102 plus PWA
Monitoring of Arterial Stiffness and Central Aortic Pressure
• Tanita MC780 MA S
The device measured the size of total body water (TBW), Extra Cellular Water (ECW), Intra Cellular Water (ICW), 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 Mazowian

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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.000 — 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: — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Differences in pulse wave velocity [m/s] in short postoperative period. Assessment will be performed one day before kidney transplantation and two days after kidney transplantation 3 days (one day before kidney transplantation and two days after kidney transplantation)
Secondary Differences in central aortic pressure [mmHg] in short postoperative period. Assessment will be performed one day before kidney transplantation and two days after kidney transplantation 3 days (one day before kidney transplantation and two days after kidney transplantation)
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