Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis

Hemodialysis Complication Clinical Trial

Official title:

Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis Measured by Non-invasive Monitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901794
• Other study ID #: 201702064RIPB
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Hemodialysis Complication
• Hemodialysis-Induced Symptom

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