HypotensionCOMAP-ICUNCT04639037
Control Mean Arterial Pressure in the Intensive Care Unit
A study testing Automated adjustment of vasopressor and Manual adjustment of vasopressor in people with Hypotension, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The goal of this randomized controlled trial is to compare two different strategies of postoperative mean arterial pressure (MAP) management (manual versus automated) in patients who underwent a major surgery and admitted in the intensive care unit or post-anesthesia care unit for postoperative care. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Automated adjustment of vasopressor and Manual adjustment of vasopressor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Jan 2021to 26 Jan 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients (>18 years)
- Patients in the intensive care or post-anesthesia care unit after a major surgery and requiring norepinephrine infusion to maintain a MAP of 80-90 mmHg.
- Patients equipped with an advanced hemodynamic monitoring device as standard of care during the surgery.
- Patient with a social security number
Who cannot join
- Patients refusing to participate
Trial locations and contacts
2 sites in 1 country.
France2 sites
Bicêtre Hospital
Le Kremlin-Bicêtre, 94270
Paul Brousse Hospital
Villejuif, 94800
About this study
Official title: Tight Postoperative Control of Mean Arterial Pressure Using a Closed-loop System for Norepinephrine Administration: A Randomized Controlled Trial in Patients Admitted to the Intensive Care Unit After a Major Surgery.
The goal of this randomized controlled trial is to compare two different strategies of postoperative mean arterial pressure (MAP) management (manual versus automated) in patients who underwent a major surgery and admitted in the intensive care unit or post-anesthesia care unit for postoperative care. The investigators hypothesis is that the automated group will spend more time in a predetermined target MAP range of 80-90 mmHg compared to the manual group.
Read the detailed description
Although the correction of hypotension during the perioperative period should be a key goal, approximately 40% of overall mortality is still closely linked to the presence of perioperative hypotension which is responsible for significant morbidity particularly in patients undergoing major surgery. Indeed, inadequate management of perioperative hypotension remains an undeniable risk factor for morbidity and mortality. However, management of perioperative mean arterial pressure (MAP) is still suboptimal today. Indeed, the analysis of our database demonstrates that, on average, patient spends only 50-60 % of the treatment time within the predetermined MAP target. In about 10% of the treatment time, the patient is under-treated (hypotension) and 30% of the time, the patient is over-treated (hypertension).
The correction of hypotension is achieved using vasopressor drugs (mainly norepinephrine infusion). In 2017 a study published in the JAMA shows that patients with tightly controlled arterial pressure have fewer organ dysfunctions than those with standard blood pressure management. However, maintaining MAP within a narrow range involves regular manual adjustments of norepinephrine infusion doses by intensive care unit nurses. When a hypotension occurs, there is usually two main possible treatments (fluid or vasopressors). In the operating room, for patients undergoing major surgery, we usually optimize fluid and vasopressor titration using an advanced hemodynamic monitoring device "EV1000 monitor" (Edwards Lifesciences, Irvine USA).This monitoring device can also be connected to a computer that controls a norepinephrine infusion pump in order to tightly adjust the infusion of norepinephrine to the target MAP predetermined by the clinician in charge of the patients. We have recently demonstrated that the use of such system resulted in less intraoperative time in hypotension compared to manual management. However, in the postoperative period, in patients admitted in the intensive care unit after a major surgery and requiring tight control of MAP, such demonstration is still lacking.
Therefore, the objective of this randomized controlled superiority study is to demonstrate that, in patients admitted to intensive care unit or post-anesthesia care unit after a major surgery, tight control of MAP using a closed-loop system for vasopressor administration will result in MAP being more often within a predetermined MAP range of 80-90 mmHg compared to the same management without this automated closed-loop system (nurse adjustment of vasopressor administration).
- Conditions
- Hypotension
- Being tested
- Automated adjustment of vasopressor, Manual adjustment of vasopressor
- Keywords
- Intraoperative hypotension, intensive care unit, hemodynamic management
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated adjustment of vasopressorDevice
The objective of this randomized controlled superiority study is to demonstrate that, in patients admitted to intensive care after a major surgery, tight control of MAP using a closed-loop system for vasopressor administration will result in MAP being more often within a MAP range of 80-90 mmHg compared to the same management without this automated closed-loop system (nurse adjustment of vasopressor administration)
Manual adjustment of vasopressorDevice
Fluid and vasopressor will be delivered as standard of care (manual adjustment of both fluid and vasopressor infusion rate by the nurse)
| Study group | Role | What they receive |
|---|---|---|
| Manual adjustment of vasopressor | Active comparator | Fluid and vasopressor will be managed as standard practice guided by the EV1000 monitoring device (manually infusion of both fluid and vasopressors) Objective being to maintain MAP within a target MAP range of 80-90 mmHg (fluid will be optimized and stroke volume index will be maintained within normal values) Receives: Device: Manual adjustment of vasopressor |
| Automated adjustment of vasopressor | Experimental | Fluid will be managed using the EV1000 monitoring in order to optimize stroke volume index and vasopressor will be automatically deliver by a closed-loop system to maintain the MAP within the target range of 80-90 mmHg Receives: Device: Automated adjustment of vasopressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of treatment time with a mean arterial pressure within 80-90 mmHg
Percentage of treatment time in target (defined as a mean arterial pressure within 80-90 mmHg)
Measured: at DAY 0
Secondary outcomes (6)
Percentage of treatment time in hypertension (MAP > 90 mmHg)
Percentage of treatment time in hypertension (defined as a MAP > 90 mmHg)
Measured: at DAY 0
Percentage of treatment time in hypotension (MAP < 80 mmHg)
Percentage of treatment time in hypotension (defined as a MAP < 80 mmHg)
Measured: at DAY 0
Percentage of treatment time in hypotension (MAP < 65 mmHg)
Percentage of treatment time in hypotension (defined as a MAP < 65 mmHg) which is the usual population target to correct
Measured: at DAY 0
Volume of fluid during the treatment time
Volume of fluid during the treatment time
Measured: at DAY 0
Amount of vasopressor used during the treatment time
total amount of vasopressor (norepinephrine) used during the treatment time to maintain MAP within 80-90 mmHg
Measured: at DAY 0
Length of stay in the intensive care unit
length of stay in the intensive care unit (discharge at the discretion of the clinician in charge of the patient and not involved in the study protocol)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start8 Jan 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active comparator (manual adjustment of vasopressor infusion) and Experimental (automated management of vasopressor infusion)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine, University of California, Los Angeles, Erasme University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639037
- Sponsor's protocol ID
- APHP200709
- Acronym
- COMAP-ICU
- Status last verified
- Apr 2022
- First submitted
- 5 Nov 2020
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Postoperative Control of Mean Arterial Pressure Using a Closed-loop System for Norepinephrine Administration: A Randomized Controlled Trial in Patients Admitted to the Intensive Care Unit After a Major Surgery.
- ClinicalTrials.gov ID
- NCT04639037
- Acronym / sponsor ID
- COMAP-ICU / APHP200709
- Conditions
- Hypotension
- Keywords
- Intraoperative hypotension, intensive care unit, hemodynamic management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- University of California, Irvine, University of California, Los Angeles, Erasme University Hospital
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 20 Nov 2020 (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 goal of this randomized controlled trial is to compare two different strategies of postoperative mean arterial pressure (MAP) management (manual versus automated) in patients who underwent a major surgery and admitted in the intensive care unit or post-anesthesia care unit for postoperative care. The investigators hypothesis is that the automated group will spend more time in a predetermined target MAP range of 80-90 mmHg compared to the manual group.
Detailed description
Although the correction of hypotension during the perioperative period should be a key goal, approximately 40% of overall mortality is still closely linked to the presence of perioperative hypotension which is responsible for significant morbidity particularly in patients undergoing major surgery. Indeed, inadequate management of perioperative hypotension remains an undeniable risk factor for morbidity and mortality. However, management of perioperative mean arterial pressure (MAP) is still suboptimal today. Indeed, the analysis of our database demonstrates that, on average, patient spends only 50-60 % of the treatment time within the predetermined MAP target. In about 10% of the treatment time, the patient is under-treated (hypotension) and 30% of the time, the patient is over-treated (hypertension).
The correction of hypotension is achieved using vasopressor drugs (mainly norepinephrine infusion). In 2017 a study published in the JAMA shows that patients with tightly controlled arterial pressure have fewer organ dysfunctions than those with standard blood pressure management. However, maintaining MAP within a narrow range involves regular manual adjustments of norepinephrine infusion doses by intensive care unit nurses. When a hypotension occurs, there is usually two main possible treatments (fluid or vasopressors). In the operating room, for patients undergoing major surgery, we usually optimize fluid and vasopressor titration using an advanced hemodynamic monitoring device "EV1000 monitor" (Edwards Lifesciences, Irvine USA).This monitoring device can also be connected to a computer that controls a norepinephrine infusion pump in order to tightly adjust the infusion of norepinephrine to the target MAP predetermined by the clinician in charge of the patients. We have recently demonstrated that the use of such system resulted in less intraoperative time in hypotension compared to manual management. However, in the postoperative period, in patients admitted in the intensive care unit after a major surgery and requiring tight control of MAP, such demonstration is still lacking.
Therefore, the objective of this randomized controlled superiority study is to demonstrate that, in patients admitted to intensive care unit or post-anesthesia care unit after a major surgery, tight control of MAP using a closed-loop system for vasopressor administration will result in MAP being more often within a predetermined MAP range of 80-90 mmHg compared to the same management without this automated closed-loop system (nurse adjustment of vasopressor administration).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Active comparator (manual adjustment of vasopressor infusion) and Experimental (automated management of vasopressor infusion)
| Arm | Type | Receives |
|---|---|---|
| Manual adjustment of vasopressor | Active comparator | Device: Manual adjustment of vasopressorFluid and vasopressor will be managed as standard practice guided by the EV1000 monitoring device (manually infusion of both fluid and vasopressors) Objective being to maintain MAP within a target MAP range of 80-90 mmHg (fluid will be optimized and stroke volume index will be maintained within normal values) |
| Automated adjustment of vasopressor | Experimental | Device: Automated adjustment of vasopressorFluid will be managed using the EV1000 monitoring in order to optimize stroke volume index and vasopressor will be automatically deliver by a closed-loop system to maintain the MAP within the target range of 80-90 mmHg |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Patients (>18 years)
- Patients in the intensive care or post-anesthesia care unit after a major surgery and requiring norepinephrine infusion to maintain a MAP of 80-90 mmHg.
- Patients equipped with an advanced hemodynamic monitoring device as standard of care during the surgery.
- Patient with a social security number
Key exclusion criteria (1 listed)
- Patients refusing to participate
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 |
|---|---|---|
| Automated adjustment of vasopressorThe objective of this randomized controlled superiority study is to demonstrate that, in patients admitted to intensive care after a major surgery, tight control of MAP using a closed-loop system for vasopressor administration will result in MAP being more often within a MAP range of 80-90 mmHg compared to the same management without this automated closed-loop system (nurse adjustment of vasopressor administration) | Device | Automated adjustment of vasopressor |
| Manual adjustment of vasopressorFluid and vasopressor will be delivered as standard of care (manual adjustment of both fluid and vasopressor infusion rate by the nurse) | Device | Manual adjustment of vasopressor |
Primary outcome
Percentage of treatment time with a mean arterial pressure within 80-90 mmHg
Time frame: at DAY 0
Percentage of treatment time in target (defined as a mean arterial pressure within 80-90 mmHg)
6 secondary outcomes
Percentage of treatment time in hypertension (MAP > 90 mmHg)
Time frame: at DAY 0
Percentage of treatment time in hypotension (MAP < 80 mmHg)
Time frame: at DAY 0
Percentage of treatment time in hypotension (MAP < 65 mmHg)
Time frame: at DAY 0
Volume of fluid during the treatment time
Time frame: at DAY 0
Amount of vasopressor used during the treatment time
Time frame: at DAY 0
Length of stay in the intensive care unit
Time frame: up to 24 hours
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 3 May 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated adjustment of vasopressor and Manual adjustment of vasopressor in people with Hypotension, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 1 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 3 May 2022. 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.
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?
Percentage of treatment time with a mean arterial pressure within 80-90 mmHg (time frame: at DAY 0). 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 3 May 2022.