NCT03901794

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

March 11, 2019

Last Update Submit

April 2, 2019

Conditions

Hemodialysis ComplicationHemodialysis-Induced Symptom

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

With Clear Sight

record and observe the data including SVI, CI, SVR with clearSight during hemodialysis

Device: Non-invasive hemodynamic monitor

Interventions

Non-invasive hemodynamic monitorDEVICE

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

With Clear Sight

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

end-stage renal disease patients who were under regular hemodialysis

You may qualify if:

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

You may not qualify if:

  • Emergent hemodialysis
  • Medical conditions with poor peripheral circulation such as Raynaud's disease or PAOD
  • Skin defects or wounds over area to be applied for measurement (Wrist and fingers)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35574491DERIVED

Study Officials

  • ST Chen

    National Taiwan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

April 3, 2019

Study Start

May 6, 2017

Primary Completion

November 23, 2018

Study Completion

November 30, 2018

Last Updated

April 3, 2019

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)