Hemodialysis ComplicationNCT03901794
Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis
An observational study of Hemodialysis Complication and Hemodialysis-Induced Symptom, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Relationship between hemodynamic change and fluid removed during hemodialysis measured by non-invasive monitor Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemodialysis Complication, Hemodialysis-Induced Symptom
- What is being tested?
- Non-invasive hemodynamic monitor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 May 2017to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: end-stage renal disease patients who were under regular hemodialysis
Who may be able to join
- 1. Patients who were schedured with regular hemodialysis for end-stage renal disease.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Non-invasive hemodynamic monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive hemodynamic monitorDevice
MAP, HR, CO, SVI, from Non-invasive hemodynamic monitor
| Study group | Role | What they receive |
|---|---|---|
| With Clear Sight | record and observe the data including SVI, CI, SVR with clearSight during hemodialysis Receives: Device: Non-invasive hemodynamic monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid removed along with hemodialysis
the fluid volume removed from hemodialysis (mL/hour),
Measured: 4 hours
changes of mean arterial pressure along with hemodialysis
record of mean arterial pressure (mmHg) per 30 minutes
Measured: 4 hours
changes of heart rate along with hemodialysis
record of heart rate (beats/ minute) per 30 minutes
Measured: 4 hours
changes of stroke volume along with hemodialysis
record of stroke volume (SV, (mL/ beat)per 30 minutes
Measured: 4 hours
changes of cardiac output along with hemodialysis
record of cardiac output ( liter/ minute)per 30 minutes
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start6 May 2017
- Primary completion23 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ST Chen, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901794
- Sponsor's protocol ID
- 201702064RIPB
- Status last verified
- Apr 2017
- First submitted
- 11 Mar 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 35574491
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis Measured by Non-invasive Monitor
- ClinicalTrials.gov ID
- NCT03901794
- Acronym / sponsor ID
- 201702064RIPB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 May 2017 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Relationship between hemodynamic change and fluid removed during hemodialysis measured by non-invasive 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| With Clear Sight | – | Device: Non-invasive hemodynamic monitorrecord and observe the data including SVI, CI, SVR with clearSight during hemodialysis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- end-stage renal disease patients who were under regular hemodialysis
Key inclusion criteria (1 listed)
- 1. Patients who were schedured with regular hemodialysis for end-stage renal disease.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive hemodynamic monitorMAP, HR, CO, SVI, from Non-invasive hemodynamic monitor | Device | With Clear Sight |
Primary outcome
fluid removed along with hemodialysis
Time frame: 4 hours
the fluid volume removed from hemodialysis (mL/hour),
changes of mean arterial pressure along with hemodialysis
Time frame: 4 hours
record of mean arterial pressure (mmHg) per 30 minutes
changes of heart rate along with hemodialysis
Time frame: 4 hours
record of heart rate (beats/ minute) per 30 minutes
changes of stroke volume along with hemodialysis
Time frame: 4 hours
record of stroke volume (SV, (mL/ beat)per 30 minutes
changes of cardiac output along with hemodialysis
Time frame: 4 hours
record of cardiac output ( liter/ minute)per 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Derived from this study: PubMed 35574491Lai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ST Chen study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Complication and Hemodialysis-Induced Symptom, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid removed along with hemodialysis (time frame: 4 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.