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AnesthesiaPhase 2Closed LoopNCT02138942

Automated Administration of Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia

A Phase 2 study testing Learning Intravenous Resuscitator (LIR) system in people with Anesthesia, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main objective of this study is to demonstrate that the LIR (Learning Intravenous Resuscitator) Closed-Loop Fluid Administration System (hereafter the "LIR system"), a new device for the automated administration of intravenous fluids during major abominal surgery and which allows the reinjection of 250 ml of… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Anesthesia
What is being tested?
Learning Intravenous Resuscitator (LIR) system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesFrance
Study dates
17 Nov 2014to 28 Dec 2016
Phase
Phase 2
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

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient will receive general anesthesia for a surgical procedure with the following characteristics: ----- planned abdominal surgery by laparotomy or laparoscopy with a probable duration> 2 hours ----- invasive monitoring of blood pressure ----- administration of crystalloid and colloid (HEA PM <150 kDa)

Who cannot join

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
Show all 14Show fewer
  • The patient has a contraindication for a treatment used in this study: ----- Contraindications to the administration of HES MW <150 kDa ----- Patient classified NYHA> 2 ----- Allergy to HEA
  • The patient has a pacemaker
  • Surgery with cardiopulmonary bypass
  • Surgery on the skull
  • Dementia
  • Patients with brain pathology (tumor, stroke, Parkinson's disease, ...)
  • Patients with a psychiatric disorder, severe depression or psychosis, as well as those receiving antipsychotic treatment
  • Limitations concerning the use of respiratory pulse pressure variation: cardiac arrhythmia, spontaneous ventilation, using a volume flow <7 ml / kg

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHRU de Montpellier - Hôpital Saint-Eloi

    Montpellier, 34295

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: Automated Administration of Intravenous Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia: a Pilot Feasibility Study

The main objective of this study is to demonstrate that the LIR (Learning Intravenous Resuscitator) Closed-Loop Fluid Administration System (hereafter the "LIR system"), a new device for the automated administration of intravenous fluids during major abominal surgery and which allows the reinjection of 250 ml of saline filling (crystalloid or colloid), maintains blood volume at values that are acceptable by the "gold standard", i.e. the anesthetist in charge of the patient.

Read the detailed description

This is a prospective, bi-center, open "Phase II" type study on a medical device (the LIR system). It is the first trial of the device on humans.

The study, which begins at the signing of consent (made the day before or the day of surgery), ends when the patient leaves the hospital. The LIR system is used on a small population of patients under general anesthesia for the automated administration of intravenous fluids during major abdominal surgery by laparotomy or laparoscopy. Several criteria describing the fluids administered, cardiac output, blood pressure and other parameters will be identified during surgery.

This Phase II study is carried out in two, subsequent stages of size "n1" = 19 and "n" = 42.

Strengthening of security :

  • The device will be used under the direct supervision of an anesthesiologist ; he / she can regain control instantly when needed .
  • An independent oversight committee will be formed and consulted every 10 patients.
Conditions
Anesthesia
Being tested
Learning Intravenous Resuscitator (LIR) system
Keywords
automated vascular filling, Learning Intravenous Resuscitator (LIR), General Surgery, Fluid Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Learning Intravenous Resuscitator (LIR) systemDevice

    The usual patient pathways and recommendations concerning vascular filling remain strictly unchanged in this study. The only thing that differs from usual care is the use of the LIR system to automatically optimize fluid resuscitation during general anesthesia, with continuous supervision by the anesthesiologist present during the entire period of use of the device.

Study groups in NCT02138942
Study groupRoleWhat they receive
The study populationExperimentalSee inclusion/exclusion criteria. Intervention: LIR
Receives: Device: Learning Intravenous Resuscitator (LIR) system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of fluid (crystalloid or colloid) administration changes per patient performed by the LIR system and approved / accepted by the participating anesthetist.

    A change may be non-validated in the following two situations:

    1. Stopping criteria when using the LIR system:
    • malfunction of the device
    • malfunction of the electric syringe (Agilia, Fresenius Kabi, Germany)
    • an abnormality of cardiac output measurement or appearance of a limitation to the use of pulse pressure variation (cardiac arrhythmia, spontaneous ventilation, tidal volume <7 ml / kg of theoretical ideal weight).
    1. Non-validation criteria for fluid administration despite a positive indication by the LIR device: If the answer to the two following questions are both yes, preventing the LIR device from acting is not theoretically justified, and the anesthesiologist must justify stopping the device and record the reason for his/her non-validation of the administration of fluid therapy.
    • The last fill increased cardiac output more than 15%? yes/no
    • The prediction parameter for filling response (pulse pressure variation) indicates vascular filling? yes/no

    Measured: Day 0, just after surgery

Secondary outcomes (38)

  1. The number of fluid administration modifications (cristalloid or colloid) performed by the device

    Measured: Day 0, just after surgery

  2. The number of times the anesthetist in charge of the patient had to intervene with the fluid administration (cristalloid or colloid) system/device.

    Measured: Day 0, just after surgery

  3. The total volume of HEA and crystalloid infused during the preload optimizations and cardiac output

    Measured: Day 0, just after surgery

  4. The total amount of crystalloid administered for basic inputs during surgery

    Measured: Day 0, just after surgery

  5. The total amount of intravenous fluids administered during surgery

    Measured: Day 0, just after surgery

  6. The mean cardiac output during surgery (liters of blood per minute)

    Measured: Day 0, just after surgery

  7. The maximum cardiac output during surgery (liters of blood per minute)

    Measured: Day 0, just after surgery

  8. The minimum cardiac output during surgery (liters of blood per minute)

    Measured: Day 0, just after surgery

  9. Cardiac output at the end of surgery (liters of blood per minute)

    Measured: Day 0, just after surgery

  10. The percent % variation in cardiac output during surgery

    Measured: Day 0, just after surgery

  11. Mean blood pressure during surgery

    Measured: Day 0, just after surgery

  12. Minimum blood pressure during surgery

    Measured: Day 0, just after surgery

  13. Maximum blood pressure during surgery

    Measured: Day 0, just after surgery

  14. % variation in blood pressure during surgery

    Measured: Day 0, just after surgery

  15. Blood pressure at the end of surgery

    Measured: Day 0, just after surgery

  16. The percentage of time during which the LIR system maintained an optimal/maximal cardiac output.

    Maximizing cardiac output is defined as the cardiac output value for which a vascular filling (250 ml saline filling) causes less than 10% increase in stroke volume.

    Measured: Day 0 (at the end of surgery)

  17. The minutes required to achieve maximized cardiac output.

    Measured: Day 0 (at the end of surgery)

  18. The percentage of time spent in hypotension.

    Measured: Day 0 (at the end of surgery)

  19. The number of hypotension and hypertension episodes requireing treatment.

    Measured: Day 0 (just after surgery)

  20. Pulse pressure variation throughout surgery

    Measured: Day 0 (just after surgery)

  21. Stroke volume throughout surgery

    Measured: Day 0 (just after surgery)

  22. Stroke volume variation

    Measured: Day 0 (just after surgery)

  23. Blood lactate

    Measured: Day 0 (at the end of surgery)

  24. % oxygen saturation of central venous blood

    Measured: Day 0 (at the end of surgery)

  25. Intraoperative urine output

    Measured: Day 0 (at the end of surgery)

  26. The occurrence of postoperative complications defined by POSSUM criteria

    Measured: Day 0 to 3; discharge from the post-intervention monitoring room

  27. Medical device malfunctions: presence/absence

    Measured: Day 0 to 3; discharge from the post-intervention monitoring room

  28. Admission to ICU; yes/no

    Measured: Day 0 to 3; discharge from the post-intervention monitoring room

  29. Length of stay in ICU

    Measured: Day 0 to 3; discharge from the post-intervention monitoring room

  30. Length of hospital stay

    Measured: Hospital discharge; expected maximum of 28 days

  31. The period between the end of surgery and the recovery of audible gastrointestinal transit (auscultation; gas and stool)

    Measured: Hospital discharge; expected maximum of 28 days

  32. The period between the end of surgery and the recovery of a liquid diet

    Measured: Hospital discharge; expected maximum of 28 days

  33. The period between the end of surgery and the resumption of solid food

    Measured: Hospital discharge; expected maximum of 28 days

  34. The period between the end of surgery and the recovery of intestinal transit

    Measured: Hospital discharge; expected maximum of 28 days

  35. Creatinemia

    Measured: Baseline (day 0)

  36. Creatinemia

    Measured: Day 1

  37. Creatinemia

    Measured: Day 2

  38. Creatinemia

    Measured: Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2014 (estimated)
  2. Study start17 Nov 2014
  3. Primary completion28 Dec 2016
  4. Study completion28 Dec 2016

Why it stopped: non-compliance with the protocol. Arrest requested by the Monitoring Safety committee

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02138942
Sponsor's protocol ID
AOI/2012/RC-01
Other IDs
2013-A01186-39
Acronym
Closed Loop
Status last verified
Jan 2018
First submitted
13 May 2014
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Gricourt Y, Prin Derre C, Demattei C, Bertran S, Louart B, Muller L, Simon N, Lefrant JY, Cuvillon P, Jaber S, Roger C. A Pilot Study Assessing a Closed-Loop System for Goal-Directed Fluid Therapy in Abdominal Surgery Patients. J Pers Med. 2022 Aug 30;12(9):1409. doi: 10.3390/jpm12091409.

    PubMed 36143194

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Learning Intravenous Resuscitator (LIR) system in people with Anesthesia, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 14 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: non-compliance with the protocol. Arrest requested by the Monitoring Safety committee). 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?

The percentage of fluid (crystalloid or colloid) administration changes per patient performed by the LIR system and approved / accepted by the participating anesthetist. (time frame: Day 0, just after surgery). 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 NCT02138942, 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 17 Nov 2025.

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