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Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03901794
Recruitment Status : Completed
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
Relationship between hemodynamic change and fluid removed during hemodialysis measured by non-invasive monitor

Condition or disease Intervention/treatment
Hemodialysis Complication Hemodialysis-Induced Symptom Device: Non-invasive hemodynamic monitor

Detailed Description:
By applying non-invasive hemodynamic monitors (ex. ClearSight, I-COM), the trends of mean arterial pressure (MAP), stroke volume (SV), cardiac index (CI) and calculated systemic vascular resistance (SVR) were collected along with volume removal by hemodialysis on ESRD patients. All data were compared and analyzed to detect the sequential body volume status as well as the autonomic responses during hemodialysis.
Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis Measured by Non-invasive Monitor
Actual Study Start Date : May 6, 2017
Actual Primary Completion Date : November 23, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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Group/Cohort Intervention/treatment
With Clear Sight
record and observe the data including SVI, CI, SVR with clearSight during hemodialysis
 Device: Non-invasive hemodynamic monitor
MAP, HR, CO, SVI, from Non-invasive hemodynamic monitor


Outcome Measures
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Primary Outcome Measures :
  1. fluid removed along with hemodialysis [ Time Frame: 4 hours ]
    the fluid volume removed from hemodialysis (mL/hour),

  2. changes of mean arterial pressure along with hemodialysis [ Time Frame: 4 hours ]
    record of mean arterial pressure (mmHg) per 30 minutes

  3. changes of heart rate along with hemodialysis [ Time Frame: 4 hours ]
    record of heart rate (beats/ minute) per 30 minutes

  4. changes of stroke volume along with hemodialysis [ Time Frame: 4 hours ]
    record of stroke volume (SV, (mL/ beat)per 30 minutes

  5. changes of cardiac output along with hemodialysis [ Time Frame: 4 hours ]
    record of cardiac output ( liter/ minute)per 30 minutes


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
end-stage renal disease patients who were under regular hemodialysis
Criteria

Inclusion criteria:

1. Patients who were schedured with regular hemodialysis for end-stage renal disease.

Exclusion criteria:

  1. Emergent hemodialysis
  2. Medical conditions with poor peripheral circulation such as Raynaud's disease or PAOD
  3. Skin defects or wounds over area to be applied for measurement (Wrist and fingers)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901794


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: ST Chen National Taiwan University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03901794    
Other Study ID Numbers: 201702064RIPB
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes