Hemodynamic Parameters Changes in the Course of Hemodialysis Sessions in Patients With Intradialytic Hypertension
1 other identifier
observational
22
1 country
1
Brief Summary
While the exact pathogenesis of Intradialytic hypertension remains to be determined, several mechanisms were proposed to be involved. The main factors to determine the arterial blood pressure are the peripheral vascular resistance and cardiac output. The assumption is that the increase of blood pressure is related to the increase in peripheral vascular resistance during the dialysis session, due to fluid removal and fast reduction of the intravascular volume reduction. Using the NICAS device (Non-Invasive Cardiac System), the hemodynamic profile in patients with intradialytic hypertension will be evaluated
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 11, 2019
June 1, 2019
1.1 years
January 25, 2017
June 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Peripheral vascular resistance (dyne/sec/cm5)
In patients with intradialytic hypertension
During 3 consecutive hemodialysis session in one week
Stroke volume (ml)
In patients with intradialytic hypertension
During 3 consecutive hemodialysis session in one week
Stroke index (ml/m2)
In patients with intradialytic hypertension
During 3 consecutive hemodialysis session in one week
Cardiac output (l/min)
In patients with intradialytic hypertension
During 3 consecutive hemodialysis session in one week
Cardiac index (l/min/m2)
In patients with intradialytic hypertension
During 3 consecutive hemodialysis session in one week
Heart rate (bpm)
In patients with intradialytic hypertension
During 3 consecutive hemodialysis session in one week
blood pressure (mm/Hg)
In patients with intradialytic hypertension
During 3 consecutive hemodialysis session in one week
Eligibility Criteria
Twenty two patients on Chronic Hemodialysis treatment that exhibit intradialytic hypertension in the dialysis unit in the Galilee Medical Center will be included during 2016-2017.
You may qualify if:
- Intradialytic hypertension at least once weakly
- Age older than 18 years
- Chronic hemodialysis treatment more than 3 months
- Stable dialysis treatment conditions
- Stable antihypertensive treatment for the last 4 weeks prior the study
- Patients able and agree to sign the consent form.
You may not qualify if:
- Recent changes in the antihypertensive treatment
- Recent acute cardiovascular event
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Galilee Hospital
Nahariya, Israel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 31, 2017
Study Start
November 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
June 11, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share