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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03901794
Other study ID # 201702064RIPB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 6, 2017
Est. completion date November 30, 2018

Study information

Verified date April 2017
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Relationship between hemodynamic change and fluid removed during hemodialysis measured by non-invasive monitor


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 30, 2018
Est. primary completion date November 23, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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)

Study Design


Intervention

Device:
Non-invasive hemodynamic monitor
MAP, HR, CO, SVI, from Non-invasive hemodynamic monitor

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary fluid removed along with hemodialysis the fluid volume removed from hemodialysis (mL/hour), 4 hours
Primary changes of mean arterial pressure along with hemodialysis record of mean arterial pressure (mmHg) per 30 minutes 4 hours
Primary changes of heart rate along with hemodialysis record of heart rate (beats/ minute) per 30 minutes 4 hours
Primary changes of stroke volume along with hemodialysis record of stroke volume (SV, (mL/ beat)per 30 minutes 4 hours
Primary changes of cardiac output along with hemodialysis record of cardiac output ( liter/ minute)per 30 minutes 4 hours
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