Post-Op ComplicationOPHIQUENCT03852147
Individualized Hemodynamic Optimization by Indirect Measurement of the Respiratory Quotient in Major Surgery: Prospective Randomized Multicentre Open-Label Study (OPHIQUE) Individualized Optimization by Indirect Measurement of the Respiratory Quotient
A study testing : hemodynamic management in people with Post-Op Complication and Respiratory Complication, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The measurement of the inspired / expired fractions in O2 and CO2 is part of the daily monitoring of the intubated-ventilated patient in the operating theater. The ratio of VCO2 to VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of the patient, and an indirect reflection of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Op Complication, Respiratory Complication
- What is being tested?
- : hemodynamic management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 26 Dec 2018to 26 Jan 2023
- 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
- Abdominal, orthopedic or vascular surgery with general anesthesia
- ASA score ≥ II
- Estimated duration of surgery> 2 hours
- Consent signed.
- Affiliation to a social security scheme
Who cannot join
- Untreated or unbalanced severe hypertension under treatment.
- Preoperative renal failure dialyzed.
- Acute heart failure.
- Acute coronary insufficiency.
- Vascular surgery with kidney plasty.
- Cardiac surgery.
Show all 16Show fewer
- Permanent laparoscopy.
- Preoperative shock state.
- Refusal of patient's participation
- Pregnant woman, parturient or breastfeeding.
- Patient under guardianship or trusteeship, under the protection of justice or private public law.
- Anesthesia with loco-regional anesthesia (spinal anesthesia and epidural).
- Acute respiratory distress syndrome (PaO2 / FiO2 ratio <300).
- Chronic Respiratory Failure with Home Oxygen Therapy.
- Patient already included in another therapeutic trial with an experimental molecule.
- Emergency anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
The measurement of the inspired / expired fractions in O2 and CO2 is part of the daily monitoring of the intubated-ventilated patient in the operating theater. The ratio of VCO2 to VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of the patient, and an indirect reflection of tissue perfusion. We hypothesize that a hemodynamic optimization in major surgery individualized by non-invasive continuous measurement of the RQ would optimize TaO2 more specifically by informing us about the installation of a VO2 dependence, and therefore of an anaerobic metabolism. Patients are randomized in 2 groups : Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of Systolic Voume (SV) by vascular filling and use of dobutamine if necessary. Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine. Primary and secondary outcomes are recorded 1,2,7 and 30 days after the surgery.
Read the detailed description
- Background : The measurement of the inspired / expired fractions in O2 and CO2 is part of the daily monitoring of the intubated-ventilated patient in the operating theater. Changes in EtCO2 may reflect changes in metabolic CO2 production (VCO2), and oxygen extraction from the body (SvO2). The inspired / exhaled oxygen difference is an indirect reflection of the oxygen consumption (VO2). The ratio of VCO2 to VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of the patient, and an indirect reflection of tissue perfusion.
Some studies, including a recent one carried out by our center, showed that the RQ was linked to the appearance of anaerobic metabolism and to the postoperative evolution of the patient. The RQ was correlated with arterial lactate levels and predicted the occurrence of postoperative complications. Thus, the RQ can be a reliable, continuous, non-invasive marker of anaerobic metabolism in the operating room and therefore of the adequacy of arterial oxygen Transport (TaO2) with respect to the VO2 of the patient
- Purpose : Th investigators hypothesize that a hemodynamic optimization in major surgery individualized by non-invasive continuous measurement of the RQ would optimize TaO2 more specifically by informing us about the installation of a VO2 dependence, and therefore of an anaerobic metabolism.
- Brief summary:
The measurement of the inspired / expired fractions in O2 and CO2 is part of the daily monitoring of the intubated-ventilated patient in the operating theater. The ratio of VCO2 to VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of the patient, and an indirect reflection of tissue perfusion. We hypothesize that a hemodynamic optimization in major surgery individualized by non-invasive continuous measurement of the RQ would optimize TaO2 more specifically by informing us about the installation of a VO2 dependence, and therefore of an anaerobic metabolism. Patients are randomized in 2 groups : Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of Systolic Voume (SV) by vascular filling and use of dobutamine if necessary. Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine. Primary and secondary outcomes are recorded 1,2,7 and 30 days after the surgery.
Number of groups and description of groups :
2 groups Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by vascular filling and use of dobutamine if necessary.
Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine.
- Interventions : Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by vascular filling and use of dobutamine if necessary.
Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine.
The primary outcome is defined by at least one organ failure within 7 days postoperatively.
The duration of participation of each patient is 30 days and total research term is 49 months
- Number of subjects : 350
- Statistical analysis : The null hypothesis will be rejected in favor of the alternative hypothesis (there is a difference) using a test of χ2 or a Fisher test according to the frequency of the complications with a risk of the first bilateral species of 5%.
- Key-words : respiratory quotient, post opérative complications, anaerobic metabolism.
- Conditions
- Post-Op Complication, Respiratory Complication
- Being tested
- : hemodynamic management
- Keywords
- respiratory quotient, post operative complications, anaerobic metabolism
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
: hemodynamic managementProcedure or surgery
Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by vascular filling and use of dobutamine if necessary.
Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by vascular filling and use of dobutamine if necessary. Receives: Procedure: : hemodynamic management |
| Experimental group | Experimental | perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine. Receives: Procedure: : hemodynamic management |
What is being measured
The primary outcome is the main question the study is designed to answer.
organ failure
at least one organ failure within 7 days postoperatively. • Organ failure is defined according to the recommendations of the European Anesthesia Society (ESA) and the European Resuscitation Society (ESICM).
Measured: 7 days postoperatively
mortality rate at day 30
Measured: 30 days
Secondary outcomes (11)
the length of stay in the hospital
Measured: 30 days
the SOFA score at day1
The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients.According to an observational study at an Intensive Care Unit (ICU) in Belgium, the mortality rate is at least 50% when the score is increased, regardless of initial score, in the first 96 hours of admission, 27% to 35% if the score remains unchanged, and less than 27% if the score is reduced. Score ranges from 0 (best) to 24 (worst) points.
Measured: 1 day
the SOFA score at day2
The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients.According to an observational study at an Intensive Care Unit (ICU) in Belgium, the mortality rate is at least 50% when the score is increased, regardless of initial score, in the first 96 hours of admission, 27% to 35% if the score remains unchanged, and less than 27% if the score is reduced. Score ranges from 0 (best) to 24 (worst) points.
Measured: 2 days
the SOFA score at day7
The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients.According to an observational study at an Intensive Care Unit (ICU) in Belgium, the mortality rate is at least 50% when the score is increased, regardless of initial score, in the first 96 hours of admission, 27% to 35% if the score remains unchanged, and less than 27% if the score is reduced. Score ranges from 0 (best) to 24 (worst) points.
Measured: 7 days
total volume of fluid intraoperatively
Measured: 30 days
Plasma creatinine measured on day 0, day 1, day 2 and day 7 postoperatively
Measured: 7 days
Plasma lactate measured on day 1, day 2 and day 7 postoperatively
Measured: 7 days
C Reactive protein measured on day1, day2 and day7 postoperative
Measured: 7 days
Troponin Tc measured on day1, day2 and day7 postoperatively
Measured: 7 days
(NT pro) Brain Natriuretic Peptide ((NT pro) BNP) measured at day1, day2 and day7 postoperative
Measured: 7 days
the incidence of each complication
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start26 Dec 2018
- Primary completion26 Dec 2022
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- st isabelle health center, abbeville, Centre Hospitalier Universitaire de Caen, Centre Hospitalier VALENCIENNES
- Responsible party
- Sponsor
- Investigators
- Stéphane Bar, Dr, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852147
- Sponsor's protocol ID
- PI2018_843_0014
- Acronym
- OPHIQUE
- Status last verified
- Sep 2025
- First submitted
- 21 Feb 2019
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bar S, Boivin P, El Amine Y, Descamps R, Moussa M, Abou Arab O, Fischer MO, Dupont H, Lorne E, Guinot PG. Individualized hemodynamic optimization guided by indirect measurement of the respiratory exchange ratio in major surgery: study protocol for a randomized controlled trial (the OPHIQUE study). Trials. 2020 Nov 23;21(1):958. doi: 10.1186/s13063-020-04879-x.
PubMed 33228773Bar S, Moussa MD, Descamps R, El Amine Y, Bouhemad B, Fischer MO, Lorne E, Dupont H, Diouf M, Guinot PG; OPHIQUE study group. Determinants of postoperative complications in high-risk noncardiac surgery patients optimized with hemodynamic treatment strategies: A post-hoc analysis of a randomized multicenter clinical trial. J Clin Anesth. 2024 May;93:111325. doi: 10.1016/j.jclinane.2023.111325. Epub 2023 Nov 22.
PubMed 37992534Bar S, Moussa MD, Descamps R, El Amine Y, Bouhemad B, Fischer MO, Lorne E, Dupont H, Diouf M, Guinot PG; OPtimization Hemodynamic Individualized using the respiratiory QUotiEnt (OPHIQUE) Trial Group. Respiratory Exchange Ratio guided management in high-risk noncardiac surgery: The OPHIQUE multicentre randomised controlled trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101221. doi: 10.1016/j.accpm.2023.101221. Epub 2023 Mar 21.
PubMed 36958473
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Hemodynamic Optimization by Indirect Measurement of the Respiratory Quotient in Major Surgery: Prospective Randomized Multicentre Open-Label Study (OPHIQUE) Individualized Optimization by Indirect Measurement of the Respiratory Quotient
- ClinicalTrials.gov ID
- NCT03852147
- Acronym / sponsor ID
- OPHIQUE / PI2018_843_0014
- Conditions
- Post-Op Complication, Respiratory Complication
- Keywords
- respiratory quotient, post operative complications, anaerobic metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- st isabelle health center, abbeville, Centre Hospitalier Universitaire de Caen, Centre Hospitalier VALENCIENNES
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 25 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 measurement of the inspired / expired fractions in O2 and CO2 is part of the daily monitoring of the intubated-ventilated patient in the operating theater. The ratio of VCO2 to VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of the patient, and an indirect reflection of tissue perfusion. We hypothesize that a hemodynamic optimization in major surgery individualized by non-invasive continuous measurement of the RQ would optimize TaO2 more specifically by informing us about the installation of a VO2 dependence, and therefore of an anaerobic metabolism. Patients are randomized in 2 groups : Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of Systolic Voume (SV) by vascular filling and use of dobutamine if necessary. Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine. Primary and secondary outcomes are recorded 1,2,7 and 30 days after the surgery.
Detailed description
- Background : The measurement of the inspired / expired fractions in O2 and CO2 is part of the daily monitoring of the intubated-ventilated patient in the operating theater. Changes in EtCO2 may reflect changes in metabolic CO2 production (VCO2), and oxygen extraction from the body (SvO2). The inspired / exhaled oxygen difference is an indirect reflection of the oxygen consumption (VO2). The ratio of VCO2 to VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of the patient, and an indirect reflection of tissue perfusion.
Some studies, including a recent one carried out by our center, showed that the RQ was linked to the appearance of anaerobic metabolism and to the postoperative evolution of the patient. The RQ was correlated with arterial lactate levels and predicted the occurrence of postoperative complications. Thus, the RQ can be a reliable, continuous, non-invasive marker of anaerobic metabolism in the operating room and therefore of the adequacy of arterial oxygen Transport (TaO2) with respect to the VO2 of the patient
- Purpose : Th investigators hypothesize that a hemodynamic optimization in major surgery individualized by non-invasive continuous measurement of the RQ would optimize TaO2 more specifically by informing us about the installation of a VO2 dependence, and therefore of an anaerobic metabolism.
- Brief summary:
The measurement of the inspired / expired fractions in O2 and CO2 is part of the daily monitoring of the intubated-ventilated patient in the operating theater. The ratio of VCO2 to VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of the patient, and an indirect reflection of tissue perfusion. We hypothesize that a hemodynamic optimization in major surgery individualized by non-invasive continuous measurement of the RQ would optimize TaO2 more specifically by informing us about the installation of a VO2 dependence, and therefore of an anaerobic metabolism. Patients are randomized in 2 groups : Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of Systolic Voume (SV) by vascular filling and use of dobutamine if necessary. Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine. Primary and secondary outcomes are recorded 1,2,7 and 30 days after the surgery.
Number of groups and description of groups :
2 groups Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by vascular filling and use of dobutamine if necessary.
Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine.
- Interventions : Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by vascular filling and use of dobutamine if necessary.
Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine.
The primary outcome is defined by at least one organ failure within 7 days postoperatively.
The duration of participation of each patient is 30 days and total research term is 49 months
- Number of subjects : 350
- Statistical analysis : The null hypothesis will be rejected in favor of the alternative hypothesis (there is a difference) using a test of χ2 or a Fisher test according to the frequency of the complications with a risk of the first bilateral species of 5%.
- Key-words : respiratory quotient, post opérative complications, anaerobic metabolism.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: : hemodynamic managementhemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by vascular filling and use of dobutamine if necessary. |
| Experimental group | Experimental | Procedure: : hemodynamic managementperioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Abdominal, orthopedic or vascular surgery with general anesthesia
- ASA score ≥ II
- Estimated duration of surgery> 2 hours
- Consent signed.
- Affiliation to a social security scheme
Key exclusion criteria (16 listed)
- Untreated or unbalanced severe hypertension under treatment.
- Preoperative renal failure dialyzed.
- Acute heart failure.
- Acute coronary insufficiency.
- Vascular surgery with kidney plasty.
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 |
|---|---|---|
| : hemodynamic managementControl group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by vascular filling and use of dobutamine if necessary. Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine. | Procedure or surgery | Control group, Experimental group |
Primary outcome
organ failure
Time frame: 7 days postoperatively
at least one organ failure within 7 days postoperatively. • Organ failure is defined according to the recommendations of the European Anesthesia Society (ESA) and the European Resuscitation Society (ESICM).
mortality rate at day 30
Time frame: 30 days
11 secondary outcomes
the length of stay in the hospital
Time frame: 30 days
the SOFA score at day1
Time frame: 1 day
the SOFA score at day2
Time frame: 2 days
the SOFA score at day7
Time frame: 7 days
total volume of fluid intraoperatively
Time frame: 30 days
Plasma creatinine measured on day 0, day 1, day 2 and day 7 postoperatively
Time frame: 7 days
Plasma lactate measured on day 1, day 2 and day 7 postoperatively
Time frame: 7 days
C Reactive protein measured on day1, day2 and day7 postoperative
Time frame: 7 days
Troponin Tc measured on day1, day2 and day7 postoperatively
Time frame: 7 days
(NT pro) Brain Natriuretic Peptide ((NT pro) BNP) measured at day1, day2 and day7 postoperative
Time frame: 7 days
the incidence of each complication
Time frame: 30 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 22 Sep 2025.
- Results publication: PubMed 33228773Bar S, Boivin P, El Amine Y, Descamps R, Moussa M, Abou Arab O, Fischer MO, Dupont H, Lorne E, Guinot PG. Individualized hemodynamic optimization guided by indirect measurement of the respiratory exchange ratio in major surgery: study protocol for a randomized controlled trial (the OPHIQUE study). Trials. 2020 Nov 23;21(1):958. doi: 10.1186/s13063-020-04879-x.
- Results publication: PubMed 37992534Bar S, Moussa MD, Descamps R, El Amine Y, Bouhemad B, Fischer MO, Lorne E, Dupont H, Diouf M, Guinot PG; OPHIQUE study group. Determinants of postoperative complications in high-risk noncardiac surgery patients optimized with hemodynamic treatment strategies: A post-hoc analysis of a randomized multicenter clinical trial. J Clin Anesth. 2024 May;93:111325. doi: 10.1016/j.jclinane.2023.111325. Epub 2023 Nov 22.
- Results publication: PubMed 36958473Bar S, Moussa MD, Descamps R, El Amine Y, Bouhemad B, Fischer MO, Lorne E, Dupont H, Diouf M, Guinot PG; OPtimization Hemodynamic Individualized using the respiratiory QUotiEnt (OPHIQUE) Trial Group. Respiratory Exchange Ratio guided management in high-risk noncardiac surgery: The OPHIQUE multicentre randomised controlled trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101221. doi: 10.1016/j.accpm.2023.101221. Epub 2023 Mar 21.
- Individual participant dataSharing planned: No
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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.
Stéphane Bar, Dr principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing : hemodynamic management in people with Post-Op Complication and Respiratory Complication, run by Centre Hospitalier Universitaire, Amiens 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 5 inclusion and 16 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 22 Sep 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. 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?
organ failure (time frame: 7 days postoperatively). The study lists 2 primary outcomes in all. 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 NCT03852147, which also lists 3 linked publications.
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 22 Sep 2025.