ThyroidectomyPhase 4NCT02122367
Study of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness
A Phase 4 study testing HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) in people with Thyroidectomy and Fluid Responsiveness, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial summary
Appropriate indices to guide fluid therapy are essential for effective hemodynamic management during the perioperative period. Values derived from respiratory changes in arterial pressure waveform or plethysmographic waveform such as stroke volume variation and pleth variability index have been demonstrated to be able… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroidectomy, Fluid Responsiveness
- What is being tested?
- HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Mar 2015
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20
- elective robot assisted thyroidectomy
Who cannot join
- arrhythmia
- BMI>30
- valvular heart disease
- pul hypertension
- peripheral artery occlusive disease
- lung disease
- right heart failure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul, Seoul, 156-755
Seong Deok Kim, MD.PhD, 82-2-6299-2571, ksddeok@cau.ac.kr
So-young Yang, MD,PhD
About this study
Official title: Validation of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness in Patients Undergoing Robot Assisted Thyroidectomy
Appropriate indices to guide fluid therapy are essential for effective hemodynamic management during the perioperative period. Values derived from respiratory changes in arterial pressure waveform or plethysmographic waveform such as stroke volume variation and pleth variability index have been demonstrated to be able to predict fluid responsiveness in surgical or critically ill patients. Their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system by position change. The aim of this prospective trial is to investigate the ability of stroke volume variation and pleth variability index to predict fluid responsiveness in the reverse trendelenberg position.
- Conditions
- Thyroidectomy, Fluid Responsiveness
- Being tested
- HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)Other
HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) 6ml/kg of ideal body weight loading
| Study group | Role | What they receive |
|---|---|---|
| stroke volume variation, pleth variability index | Experimental | stroke volume variation: recorded using the FloTrac/Vigileo system (Edwards Lifesciences)
pleth variability index: recorded using the Masimo Radical-7 monitor (Masimo Corporation, Irvine, CA, USA) Receives: Other: HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume variation
Measured: 5 minutes after volume replacement
pleth variability index
Measured: 5 minutes after volume replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Young Yang, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122367
- Sponsor's protocol ID
- Chung-Ang UH
- Status last verified
- Apr 2014
- First submitted
- 22 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness in Patients Undergoing Robot Assisted Thyroidectomy
- ClinicalTrials.gov ID
- NCT02122367
- Acronym / sponsor ID
- Chung-Ang UH
- Conditions
- Thyroidectomy, Fluid Responsiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (estimated)
- First posted
- 24 Apr 2014 (estimated)
- 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.
Appropriate indices to guide fluid therapy are essential for effective hemodynamic management during the perioperative period. Values derived from respiratory changes in arterial pressure waveform or plethysmographic waveform such as stroke volume variation and pleth variability index have been demonstrated to be able to predict fluid responsiveness in surgical or critically ill patients. Their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system by position change. The aim of this prospective trial is to investigate the ability of stroke volume variation and pleth variability index to predict fluid responsiveness in the reverse trendelenberg position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke volume variation, pleth variability index | Experimental | Other: HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)stroke volume variation: recorded using the FloTrac/Vigileo system (Edwards Lifesciences) pleth variability index: recorded using the Masimo Radical-7 monitor (Masimo Corporation, Irvine, CA, USA) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 20
- elective robot assisted thyroidectomy
Key exclusion criteria (7 listed)
- arrhythmia
- BMI>30
- valvular heart disease
- pul hypertension
- peripheral artery occlusive disease
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 |
|---|---|---|
| HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) 6ml/kg of ideal body weight loading | Other | stroke volume variation, pleth variability index |
Primary outcome
stroke volume variation
Time frame: 5 minutes after volume replacement
pleth variability index
Time frame: 5 minutes after volume replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) in people with Thyroidectomy and Fluid Responsiveness, run by Chung-Ang University Hospital at 1 site in South Korea.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Apr 2014. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact So-young Yang, clinical assistant professor (82-2-6299-3160, didth79@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke volume variation (time frame: 5 minutes after volume replacement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2014.