Hemodialysis-Induced Blood Pressure Change In End-Stage Renal Disease

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.

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Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SBMU

Tehran, 1666664321, Iran

About this study

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 Medical®,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 Medison©). A single observerwas responsible for each series of measurements, double checked.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients on maintenance hemodialysis for at least 12 hours per weeks

Exclusion criteria

Patients with symptomatic CVD
Recent major trauma
Patients who refused measurements

Treatment and study plan

Pulsevelocity

Diagnostic Test

arterial stiffness evaluation with pulsewave velocity

Other names: Echocardiography

Primary outcomes

mortality

Time frame: during the six month post starting hemodialysis

percentage of mortality during hemodialysis due to blood pressure changes

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Hemodialysis-Induced Blood Pressure Change As A Prognostic Factor In End-Stage Renal Disease

Acronym: Hemodialysis

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Jun 21, 2021
Registry last updated: Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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