AnesthesiaNCT03089710
Mini-fluid Challenge in Predicting Fluid Responsiveness During Prone Position Spine Surgery
A study testing Mini-fluid challenge in people with Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Perioperative fluid management is crucial for patients' outcome. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Mini-fluid challenge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Mar 2017to 14 Sep 2018
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving scheduled prone position spine surgery
- BMI 18.5~30 kg.m-2
Who cannot join
- age younger then 20 yrs or elder than 80 yrs
- pregnant women
- patients in intensive care units
- patients with the underlying disease including respiratory failure(FEV1/FVC < 70 % and FEV1 < 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR< 60 ml.min-1.1.73m-2), liver failure
- patients with ongoing infection
- patients allergic to voluven
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Mini-fluid Challenge in Predicting Fluid Responsiveness During Prone Position Spine Surgery
Perioperative fluid management is crucial for patients' outcome. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.
Read the detailed description
Perioperative fluid management is crucial for patients' outcome. Series of studies have indicated that adequate fluid management optimizes the cardiac out put, improves tissue perfusion, thus decrease the risk of postoperative morbidity. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. To the best of our knowledge, the efficacy of the test was not discussed in the perioperative care in prone position surgery. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.
- Conditions
- Anesthesia
- Being tested
- Mini-fluid challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-fluid challengeOther
Mini-fluid challenge test with 100mL colloid infusion in 1 min
| Study group | Role | What they receive |
|---|---|---|
| Mini-Fluid Challenge arm | Experimental | Fluid challenge test will be presented after induction of anesthesia at a steady state. Fluid challenge test includes 2 components: 100 ml colloid infusion in 1 min followed by 400 ml colloid infusion in 14 mins. Hemodynamic parameter after 1 minute of the end of the 1st and 2nd colloid infusion bolus will be collected.
Applied colloid: hydroxyethyl starch Receives: Other: Mini-fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cardiac index after fluid loading
interpretate the correlation of mini-fluid challenge and conventional fluid challenge
Measured: 3hr
Secondary outcomes (1)
pulse pressure variation(PPV)
interpretate the correlation of PPV and conventional fluid challenge
Measured: 3hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start31 Mar 2017
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089710
- Sponsor's protocol ID
- 201612021RIND
- Status last verified
- Oct 2018
- First submitted
- 22 Feb 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mini-fluid Challenge in Predicting Fluid Responsiveness During Prone Position Spine Surgery
- ClinicalTrials.gov ID
- NCT03089710
- Acronym / sponsor ID
- 201612021RIND
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 24 Mar 2017 (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.
Perioperative fluid management is crucial for patients' outcome. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.
Detailed description
Perioperative fluid management is crucial for patients' outcome. Series of studies have indicated that adequate fluid management optimizes the cardiac out put, improves tissue perfusion, thus decrease the risk of postoperative morbidity. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. To the best of our knowledge, the efficacy of the test was not discussed in the perioperative care in prone position surgery. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mini-Fluid Challenge arm | Experimental | Other: Mini-fluid challengeFluid challenge test will be presented after induction of anesthesia at a steady state. Fluid challenge test includes 2 components: 100 ml colloid infusion in 1 min followed by 400 ml colloid infusion in 14 mins. Hemodynamic parameter after 1 minute of the end of the 1st and 2nd colloid infusion bolus will be collected. Applied colloid: hydroxyethyl starch |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving scheduled prone position spine surgery
- BMI 18.5~30 kg.m-2
Key exclusion criteria (6 listed)
- age younger then 20 yrs or elder than 80 yrs
- pregnant women
- patients in intensive care units
- patients with the underlying disease including respiratory failure(FEV1/FVC < 70 % and FEV1 < 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR< 60 ml.min-1.1.73m-2), liver failure
- patients with ongoing infection
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 |
|---|---|---|
| Mini-fluid challengeMini-fluid challenge test with 100mL colloid infusion in 1 min | Other | Mini-Fluid Challenge arm |
Primary outcome
Change of cardiac index after fluid loading
Time frame: 3hr
interpretate the correlation of mini-fluid challenge and conventional fluid challenge
1 secondary outcome
pulse pressure variation(PPV)
Time frame: 3hr
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 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-fluid challenge in people with Anesthesia, 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 2 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: finished, as of the sponsor's last update on 11 Feb 2020. 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?
Change of cardiac index after fluid loading (time frame: 3hr). 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 11 Feb 2020.