Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis

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

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

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication; Hemodialysis-Induced Symptom
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

end-stage renal disease patients who were under regular hemodialysis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: ST Chen, National Taiwan University

Publications and helpful links

General Publications

• Lai CJ, Shih CC, Huang HH, Chien MH, Wu MS, Cheng YJ. Detecting Volemic, Cardiac, and Autonomic Responses From Hypervolemia to Normovolemia via Non-Invasive ClearSight Hemodynamic Monitoring During Hemodialysis: An Observational Investigation. Front Physiol. 2022 Apr 28;13:775631. doi: 10.3389/fphys.2022.775631. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2017
• Primary Completion (Actual): November 23, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 201702064RIPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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