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

NCT04933006 | Completed

• 1 other identifier: SBMU326
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis

Keywords

Echocardiography

Outcome Measures

Primary Outcomes (1)

• mortality

  percentage of mortality during hemodialysis due to blood pressure changes

  during the six month post starting hemodialysis

Interventions

Pulsevelocity DIAGNOSTIC_TEST

arterial stiffness evaluation with pulsewave velocity

Also known as: Echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients on maintenance hemodialysis for at least 12 hours per weeks

You may not qualify if:

• Patients with symptomatic CVD
• Recent major trauma
• Patients who refused measurements

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

SBMU

Tehran, 1666664321, Iran

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• SBMU SBMU

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 21, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)