AnesthesiaNCT03843411
Mini-fluid Challenge as a Predictor of Fluid Response for Pneumoperitoneum Patient
An observational study of Anesthesia, run by Changhua Christian Hospital.
Trial summary
The purpose of this study is to evaluate whether the change of stroke volume index(△SVI) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Anesthesia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Oct 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: receive operation that required pneumoperitoneum and FloTrac monitoring
Who may be able to join
- receive operation that required pneumoperitoneum and FloTrac monitoring
- ASA 1~3
- age between 20 to 70 year old
Who cannot join
- patient who cannot understand the process and aim of the study
- patient with arrhythmia
- poor heart function(LVEF<50%, severe valvular disease, CAD)
- CKD
- pregnant patient
- patients allergic to voluven
About this study
The purpose of this study is to evaluate whether the change of stroke volume index(△SVI) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum
Read the detailed description
Perioperative fluid management is significant important during surgery. The current trend tends to use goal-directed fluid therapy in surgery. Goal-directed fluid therapy refers to continuous monitoring of hemodynamic parameters during surgery and managing more accurate fluid administration based on the data obtained while promoting optimal tissue perfusion. Define fluid responsiveness with the hemodynamic parameters as to whether the cardiac output can be significantly increased after administration of fluid. Therefore, the advantage of predicting fluid responsiveness is that it can optimize the cardiac output and tissue perfusion while avoiding administering unnecessary fluid to patients.
The purpose of this study is to evaluate whether the change of stroke volume index(△SVI) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum.
- Conditions
- Anesthesia
- Keywords
- mini-fluid challenge
What is being measured
The primary outcome is the main question the study is designed to answer.
change of stroke volume index
record stroke volume index before and after mini-fluid challenge
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843411
- Sponsor's protocol ID
- 181239
- Status last verified
- Jan 2020
- First submitted
- 13 Feb 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-fluid Challenge as a Predictor of Fluid Response for Pneumoperitoneum Patient
- ClinicalTrials.gov ID
- NCT03843411
- Acronym / sponsor ID
- 181239
- Conditions
- Anesthesia
- Keywords
- mini-fluid challenge
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 18 Feb 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.
The purpose of this study is to evaluate whether the change of stroke volume index(△SVI) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum
Detailed description
Perioperative fluid management is significant important during surgery. The current trend tends to use goal-directed fluid therapy in surgery. Goal-directed fluid therapy refers to continuous monitoring of hemodynamic parameters during surgery and managing more accurate fluid administration based on the data obtained while promoting optimal tissue perfusion. Define fluid responsiveness with the hemodynamic parameters as to whether the cardiac output can be significantly increased after administration of fluid. Therefore, the advantage of predicting fluid responsiveness is that it can optimize the cardiac output and tissue perfusion while avoiding administering unnecessary fluid to patients.
The purpose of this study is to evaluate whether the change of stroke volume index(△SVI) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- receive operation that required pneumoperitoneum and FloTrac monitoring
Key inclusion criteria (3 listed)
- receive operation that required pneumoperitoneum and FloTrac monitoring
- ASA 1~3
- age between 20 to 70 year old
Key exclusion criteria (6 listed)
- patient who cannot understand the process and aim of the study
- patient with arrhythmia
- poor heart function(LVEF<50%, severe valvular disease, CAD)
- CKD
- pregnant patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change of stroke volume index
Time frame: 1 hours
record stroke volume index before and after mini-fluid challenge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Changhua Christian Hospital.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
change of stroke volume index (time frame: 1 hours). 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 30 Jan 2020.