AnesthesiaPhase 4NCT01882075
Closed-loop Fluid Administration System: Pilot Study to Evaluate Feasibility
A Phase 4 study testing Open loop and Closed-loop in people with Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
The investigators want to test during anesthesia the feasibility of a closed-loop automated fluid replacement system using cardiac output monitoring as the input value. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Open loop and Closed-loop
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Dec 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-75 years
- Scheduled for abdominal surgery under general anesthesia and requiring an invasive arterial blood pressure monitoring
- Consenting to participate in the study
Who cannot join
- Pregnant, breast feeding women
- Allergy
- Pacemaker
- Psychiatric disease, dementia, brain disease
- Contraindication to hydroxyethyl starch
- Inability to measure pulse pressure variability : arrhythmia, spontaneous breathing, or tidal volume < 7 ml/Kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated Administration of Fluid Administration Thanks to Hemodynamic Parameters and Cardiac Output During General Anesthesia
The investigators want to test during anesthesia the feasibility of a closed-loop automated fluid replacement system using cardiac output monitoring as the input value.
Read the detailed description
The optimization of the cardiac output is an important goal during anesthesia to decrease the postoperative morbidity, mortality and the care costs.
We want to test if the closed-loop fluid administration is feasible.
Two groups will be compared. In all cases:
- anesthesia will be provided by a closed-loop which aim is to maintain bispectral index between 40 and 60 using propofol and remifentanil. This method permits to have similar depths of anesthesia in all cases.
- cardiac output will be continuously monitored by LidCO. In one group, fluid replacement is decided by the physician; in the other, fluid replacement is automated using a closed-loop system.
- Conditions
- Anesthesia
- Being tested
- Open loop, Closed-loop
- Keywords
- Anesthesia, Fluid administration, Closed-loop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open loopDrug
Also called fluid replacement by Voluven(hydroxyethyl starch 130/0.4)
Closed-loopDevice
Also called fluid replacement by Voluven (hydroxyethyl starch 130/0.4) is automated (closed-loop)
| Study group | Role | What they receive |
|---|---|---|
| Open loop | Active comparator | fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device Receives: Drug: Open loop |
| Closed-loop | Experimental | Fluid replacement is automated. An algorithm has been developed ; the input value is continuous cardiac output measured by LidCO rapid device; the computer steers iv infusion of hydroxyethyl starch 130/0.4. Receives: Device: Closed-loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cardiac output index during the surgery
Measured: One day after anesthesia
Secondary outcomes (5)
Time before reaching maximizing cardiac output
Measured: One day after anesthesia
Volume of fluid replacement during surgery
Measured: One day after anesthesia
cardiac index during the surgery
Maximum and minimum values during the surgery
Measured: One day after anesthesia
arterial hypertension
Number of events treated
Measured: One day after anesthesia
Dysfunction of the closed-loop fluid device
Measured: One day after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Dysfonction of the device
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882075
- Sponsor's protocol ID
- 2012/17
- Other IDs
- 2012-A00610-43
- Status last verified
- Oct 2016
- First submitted
- 18 Jun 2013
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Administration of Fluid Administration Thanks to Hemodynamic Parameters and Cardiac Output During General Anesthesia
- ClinicalTrials.gov ID
- NCT01882075
- Acronym / sponsor ID
- 2012/17
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Fluid administration, Closed-loop
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dysfonction of the device
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Jun 2013 (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.
The investigators want to test during anesthesia the feasibility of a closed-loop automated fluid replacement system using cardiac output monitoring as the input value.
Detailed description
The optimization of the cardiac output is an important goal during anesthesia to decrease the postoperative morbidity, mortality and the care costs.
We want to test if the closed-loop fluid administration is feasible.
Two groups will be compared. In all cases:
- anesthesia will be provided by a closed-loop which aim is to maintain bispectral index between 40 and 60 using propofol and remifentanil. This method permits to have similar depths of anesthesia in all cases.
- cardiac output will be continuously monitored by LidCO. In one group, fluid replacement is decided by the physician; in the other, fluid replacement is automated using a closed-loop system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open loop | Active comparator | Drug: Open loopfluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device |
| Closed-loop | Experimental | Device: Closed-loopFluid replacement is automated. An algorithm has been developed ; the input value is continuous cardiac output measured by LidCO rapid device; the computer steers iv infusion of hydroxyethyl starch 130/0.4. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18-75 years
- Scheduled for abdominal surgery under general anesthesia and requiring an invasive arterial blood pressure monitoring
- Consenting to participate in the study
Key exclusion criteria (6 listed)
- Pregnant, breast feeding women
- Allergy
- Pacemaker
- Psychiatric disease, dementia, brain disease
- Contraindication to hydroxyethyl starch
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 |
|---|---|---|
| Open loopAlso: fluid replacement by Voluven(hydroxyethyl starch 130/0.4) | Drug | Open loop |
| Closed-loopAlso: fluid replacement by Voluven (hydroxyethyl starch 130/0.4) is automated (closed-loop) | Device | Closed-loop |
Primary outcome
Mean cardiac output index during the surgery
Time frame: One day after anesthesia
5 secondary outcomes
Time before reaching maximizing cardiac output
Time frame: One day after anesthesia
Volume of fluid replacement during surgery
Time frame: One day after anesthesia
cardiac index during the surgery
Time frame: One day after anesthesia
arterial hypertension
Time frame: One day after anesthesia
Dysfunction of the closed-loop fluid device
Time frame: One day after anesthesia
Results and safety
The study was stopped early (reason given: Dysfonction of the device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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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 Phase 4 study testing Open loop and Closed-loop in people with Anesthesia, run by Hopital Foch at 1 site in France.
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: stopped early, as of the sponsor's last update on 31 Oct 2016. 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 France. 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?
The study was stopped early (reason given: Dysfonction of the device). Results are not available in the source record.
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?
Mean cardiac output index during the surgery (time frame: One day after anesthesia). 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 31 Oct 2016.