Major Abdominal SurgeryCL vs CPNCT01950845
Automated Versus Manual Fluid Management for High Risk Abdominal Surgical Patient. A Prospective, Randomized Trial
A study testing Closed loop automated System (LIR®: learning intravenous resuscitator) and manual current practice by anesthesiologist team in people with Major Abdominal Surgery and Colorectal Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Abdominal Surgery, Colorectal Surgery, Hepatectomy
- What is being tested?
- Closed loop automated System (LIR®: learning intravenous resuscitator) and manual current practice by anesthesiologist team
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective major abdominal surgery
- Patient physical status ASA 2-4
- General anesthesia with positive pressure ventilation
- High risk surgical patient with a per operative Vigileo® cardiac output monitoring decided a priori.
Who cannot join
- Pregnant female
- Intraoperative hyperthermic chemotherapy procedure
- Patient physical status ASA more than 4
- Patient with allergy to hydroxyethyl starch
- Cardiac arrhythmia
- ventilation with tidal volume inferior 7mL/Kg
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69 495
About this study
Official title: Per Operative Fluid Optimisation Comparison of an Automated Closed-Loop System Versus Current Practice in High Risk Abdominal Surgical Patient. A Prospective, Randomized Clinical Trial.
Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. A novel closed-loop fluid administration system based on multi-parameter hemodynamic monitoring have been described recently. This prospective, randomized, surgeon and patient blinded study aims at comparing the cardiac output provided by either this closed-loop system or the anesthesiologist team in high-rish surgical patient elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon, France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of stay) between groups
- Conditions
- Major Abdominal Surgery, Colorectal Surgery, Hepatectomy, Pancreatectomy, Pancreaticoduodenectomy
- Being tested
- Closed loop automated System (LIR®: learning intravenous resuscitator), manual current practice by anesthesiologist team
- Keywords
- anesthesiology, Closed-Loop system, automated fluid management, cardiac output optimization, high risk surgical patient, major abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed loop automated System (LIR®: learning intravenous resuscitator)Device
Connection of the system to the patient under supervision of the anesthesiologist team during all the anesthesia procedure, respective of the applicability criteria for the fluid responsiveness detection.
manual current practice by anesthesiologist teamDevice
The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.
| Study group | Role | What they receive |
|---|---|---|
| Automated fluid management system (Closed-loop system) | Experimental | cardiac output Vigileo® (Edwards Lifesciences) monitoring is connected to the closed loop system that will automatically provide per operative fluid bolus to optimize cardiac output by automated detection of fluid responsiveness state. Receives: Device: Closed loop automated System (LIR®: learning intravenous resuscitator) |
| Current practice manual fluid management | Sham comparator | cardiac output Vigileo® (Edwards Lifesciences) monitoring will be used to help the anesthesiologist team to detect fluid responsiveness state for the manual fluid management optimization Receives: Device: manual current practice by anesthesiologist team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean indexed cardiac output
Measured: J1 to J12 (Within the surgical hospital length of stay)
Secondary outcomes (5)
per operative hemodynamic parameter
Measured: J1 (per operative time)
Per operative fluid administration
Measured: J1 (per operative)
Hospital length of stay
Within the surgical hospital length of stay
Measured: J1 to J12
Occurrence of a adverse event after surgery
Within the surgical hospital length of stay
Measured: an expected average of 12 days
Occurrence of a death whatever the cause
Within the surgical hospital length of stay
Measured: an expected average of 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionOct 2015
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 Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950845
- Sponsor's protocol ID
- 2012.770
- Acronym
- CL vs CP
- Status last verified
- Dec 2025
- First submitted
- 17 Sep 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lilot M, Bellon A, Gueugnon M, Laplace MC, Baffeleuf B, Hacquard P, Barthomeuf F, Parent C, Tran T, Soubirou JL, Robinson P, Bouvet L, Vassal O, Lehot JJ, Piriou V. Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial. J Clin Monit Comput. 2018 Dec;32(6):993-1003. doi: 10.1007/s10877-018-0106-7. Epub 2018 Jan 27.
PubMed 29380190
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per Operative Fluid Optimisation Comparison of an Automated Closed-Loop System Versus Current Practice in High Risk Abdominal Surgical Patient. A Prospective, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01950845
- Acronym / sponsor ID
- CL vs CP / 2012.770
- Conditions
- Major Abdominal Surgery, Colorectal Surgery, Hepatectomy, Pancreatectomy, Pancreaticoduodenectomy
- Keywords
- anesthesiology, Closed-Loop system, automated fluid management, cardiac output optimization, high risk surgical patient, major abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Sep 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.
Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. A novel closed-loop fluid administration system based on multi-parameter hemodynamic monitoring have been described recently. This prospective, randomized, surgeon and patient blinded study aims at comparing the cardiac output provided by either this closed-loop system or the anesthesiologist team in high-rish surgical patient elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon, France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of stay) between groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated fluid management system (Closed-loop system) | Experimental | Device: Closed loop automated System (LIR®: learning intravenous resuscitator)cardiac output Vigileo® (Edwards Lifesciences) monitoring is connected to the closed loop system that will automatically provide per operative fluid bolus to optimize cardiac output by automated detection of fluid responsiveness state. |
| Current practice manual fluid management | Sham comparator | Device: manual current practice by anesthesiologist teamcardiac output Vigileo® (Edwards Lifesciences) monitoring will be used to help the anesthesiologist team to detect fluid responsiveness state for the manual fluid management optimization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective major abdominal surgery
- Patient physical status ASA 2-4
- General anesthesia with positive pressure ventilation
- High risk surgical patient with a per operative Vigileo® cardiac output monitoring decided a priori.
Key exclusion criteria (6 listed)
- Pregnant female
- Intraoperative hyperthermic chemotherapy procedure
- Patient physical status ASA more than 4
- Patient with allergy to hydroxyethyl starch
- Cardiac arrhythmia
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 |
|---|---|---|
| Closed loop automated System (LIR®: learning intravenous resuscitator)Connection of the system to the patient under supervision of the anesthesiologist team during all the anesthesia procedure, respective of the applicability criteria for the fluid responsiveness detection. | Device | Automated fluid management system (Closed-loop system) |
| manual current practice by anesthesiologist teamThe anesthesiologist team will manage the fluid administration during all the anesthesia procedure. | Device | Current practice manual fluid management |
Primary outcome
Mean indexed cardiac output
Time frame: J1 to J12 (Within the surgical hospital length of stay)
5 secondary outcomes
per operative hemodynamic parameter
Time frame: J1 (per operative time)
Per operative fluid administration
Time frame: J1 (per operative)
Hospital length of stay
Time frame: J1 to J12
Occurrence of a adverse event after surgery
Time frame: an expected average of 12 days
Occurrence of a death whatever the cause
Time frame: an expected average of 12 days
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 19 Dec 2025.
- Background: PubMed 29380190Lilot M, Bellon A, Gueugnon M, Laplace MC, Baffeleuf B, Hacquard P, Barthomeuf F, Parent C, Tran T, Soubirou JL, Robinson P, Bouvet L, Vassal O, Lehot JJ, Piriou V. Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial. J Clin Monit Comput. 2018 Dec;32(6):993-1003. doi: 10.1007/s10877-018-0106-7. Epub 2018 Jan 27.
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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 Closed loop automated System (LIR®: learning intravenous resuscitator) and manual current practice by anesthesiologist team in people with Major Abdominal Surgery and Colorectal Surgery, run by Hospices Civils de Lyon 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 4 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 19 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Mean indexed cardiac output (time frame: J1 to J12 (Within the surgical hospital length of stay)). 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 NCT01950845, 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 19 Dec 2025.