Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04933006 |
Other study ID # |
SBMU326 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 1, 2021 |
Est. completion date |
January 1, 2022 |
Study information
Verified date |
January 2022 |
Source |
Shahid Beheshti University of Medical Sciences |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Cardiovascular events are still the leading cause of mortality and morbidity in patients with
ESRD including hemodialysis patients . Although the conventional risk factors of CVD are
relatively recognized in general population, an inverse epidemiologic relationship has been
reported for many CV risk factors in CKD patients, including hypertension, BMI and lipid
profile .Therefore, a comprehensive investigation is necessary to be able to do effective
risk management strategies in this population and some surrogate markers are required to be
determined for illustrating the net effect of the risk factors.
While several mechanisms have been attributed to hypertension in hemodialysis (HD) patients,
the exact pathogenesis, impact, monitoring and control of hypertension in HD patients are
still challenging subjects in clinical nephrology. Both low and high BP associate with higher
mortality in HD. But a reliable marker for defining an optimal BP in HD is still an important
question.
It seems that arterial stiffness play an axial role in the cardiovascular and renal adverse
outcomes in CKD and HD, as it is in several other populations , Arterial stiffness has been
demonstrated as an independent predictor of mortality in hemodialysis patients . However,
hemodialysis patients experience a fluctuating hemodynamic state and there are several
limitations for consecutive measurement of arterial stiffness indices such as pulse wave
velocity (PWV). Furthermore, the expensive measurement devices and expert operators might not
be available in every dialysis center.
Description:
From 60 patients who were on a HD program in a HD center in a referral hospital, fifty one
individuals were included into the study. Patients on maintenance hemodialysis, for at least
12 hours per weeks were included into the study. But, patients with symptomatic CVD, AV
fistula on both arms, acute deteriorating states and any recent major trauma or patients who
refused measurements were excluded. No change in their current medication was administered.
All patients were on maintenance HD for at least 12 months and were assumed as good volume
controlled. Dialysis protocol with a mean sp KT/V = 1.4/ session, using Bicarbonate
dialysate, dialysate flow rate = 500cc /min was applied by Fresenius B 4008machine. BP was
measured using a validated automated device (Omron-HBP1300). Pulse wave analysis was
performed using the SphygmoCor (Sydney, Atcor MedicalĀ®,2005) to assess Augmentation Index
(AIx) as a surrogate for arterial stiffness, as well as several hemodynamic measures at the
recruitment and repeated in alive individuals after 5 years of follow-up. Similarly
Echocardiography was employed at the beginnings and repeated at the end of the study by EKO 7
Cardiovascular Ultrasound System (Samsung MedisonĀ©). A single observerwas responsible for
each series of measurements, double checked.