Intraoperative HypotensionINFIVASPNCT03965793
Individualized Fluid And Vasopressor Administration In Surgical Patients
A study testing Automated management of hypotension in people with Intraoperative Hypotension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to compare two different strategies of intraoperative mean arterial pressure (MAP) and stroke volume index management in high-risk patients undergoing major abdominal and orthopedic surgery (manual versus automated) The investigators hypothesis is that the automated group will spend less… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Automated management of hypotension
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2019to 26 Jul 2020
- 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
- All adult patients scheduled for major abdominal and orthopedic surgery equipped with a cardiac output monitoring device.
Who cannot join
- Patients < 18 years old
- cardiac arrythmia (atrial fibrillation)
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Fluid and Vasopressor Administration in Surgical Patients: A Randomized Controlled Trial
The purpose of this study is to compare two different strategies of intraoperative mean arterial pressure (MAP) and stroke volume index management in high-risk patients undergoing major abdominal and orthopedic surgery (manual versus automated) The investigators hypothesis is that the automated group will spend less time during surgery in hypotension (defined as a MAP<90% of patient's MAP baseline) compared to the manual group.
Read the detailed description
The maintenance of MAP is essential for organ perfusion pressure. Intraoperative hypotension is a frequent complication both after induction and during maintenance of anaesthesia, ranging from 5% to 75% depending on the chosen definition. Tissue hypoperfusion exposes to the occurrence of a systemic inflammatory response syndrome and is a key determinant of postoperative complications. Persistent intraoperative hypotension has been reported as an important prognostic factor of postoperative morbidity and mortality. Adequate treatment of arterial hypotension is therefore of particular importance during surgery. However, the avoidance of hypotension includes the infusion of vasopressor and/or fluid to optimize perfusion pressure. The manual adjustment of vasopressor administration has been shown to be suboptimal.
Recently, a paper published in the JAMA journal demonstrated that among patients undergoing high-risk surgery, the maintenance of blood pressure within 10% of patient's baseline systolic blood pressure resulted in less postoperative organ dysfunction compared to standard MAP management.
Today, the investigators have an automated clinical decision support system that help ease the administration of both fluid and vasopressors during surgery (individualized fluid and vasopressor administration). The department of the investigators has recently implemented a manual hemodynamic protocol to optimize fluid and vasopressor. The goal is to maintain stroke volume index within 90% of the optimal stroke volume via mini fluid challenge of crystalloid solution (100 ml) following the French guidelines and to maintain MAP within 90 % of patient's baseline MAP. This protocol has been called : Individualized Fluid and vasopressor protocol (because based on patient's values) The purpose of this study is therefore to compare two different strategies of intraoperative mean arterial pressure (MAP) and stroke volume index management in high-risk surgical patients (manual versus automated and decision support guided) The investigators hypothesis is that automated group will spend less time during surgery in hypotension (defined as a MAP<90% of patient's MAP baseline) compared to the manual group because patient's stroke volume and MAP will be better maintained during surgery (within 10% of patient' targets).The decision support system will remind the clinician when to administer a bolus of fluid to maintain stroke volume index within 10% of the optimize stroke volume index value and an automated closed-lopp system will titrate norepinephrine to keep MAP within 10% of patient's MAP target. The study will thus compare an individualized hemodynamic protocol (already in place in our institution) applied manually to a decision support-and closed-loop guided- individualized hemodynamic protocol (intervention group).
- Conditions
- Intraoperative Hypotension
- Being tested
- Automated management of hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated management of hypotensionDevice
Fluid and vasopressor will be administered based on a novel automated clinical decision support system.
| Study group | Role | What they receive |
|---|---|---|
| Manual management of hypotension | Active comparator | Fluid and vasopressor will be managed as standard practice ( manually infusion of both fluid and vasopressors) following the investigators manual individualized hemodynamic protocol.(objective being to keep both stroke volume and MAP within 90 % of the target values) Receives: Device: Automated management of hypotension |
| Automated management of hypotension | Experimental | Fluid and vasopressor will be managed with a novel active clinical decision support system to guide fluid administration and automated closed-loop system to maintain MAP within 90% of patient' baseline. Receives: Device: Automated management of hypotension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of surgery time in hypotension
Percentage of surgery time in hypotension (defined as the percentage of case time the patient will spend with a MAP < 10% of patient's MAP Baseline)
Measured: at day 1
Secondary outcomes (1)
Postoperative complications incidence
Number of postoperative complications at day 30 post surgery among the 9 items (postoperative nausea and vomiting, delirium, wound infection, urinary infection, pneumonia, acute kidney injury incidence, paralytic ileus, other infections, readmission to hospital within the 30 days post surgery
Measured: at DAY 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start27 Oct 2019
- Primary completion26 Jul 2020
- Study completion26 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Joosten, MD PhD, Principal investigator, Bicetre hospital, APHP.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965793
- Sponsor's protocol ID
- APHP190369
- Acronym
- INFIVASP
- Status last verified
- Feb 2021
- First submitted
- 24 May 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Fluid and Vasopressor Administration in Surgical Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03965793
- Acronym / sponsor ID
- INFIVASP / APHP190369
- Conditions
- Intraoperative Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Oct 2019 (actual)
- Primary completion
- 26 Jul 2020 (actual)
- Study completion
- 26 Jul 2020 (actual)
- First posted
- 29 May 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 purpose of this study is to compare two different strategies of intraoperative mean arterial pressure (MAP) and stroke volume index management in high-risk patients undergoing major abdominal and orthopedic surgery (manual versus automated) The investigators hypothesis is that the automated group will spend less time during surgery in hypotension (defined as a MAP<90% of patient's MAP baseline) compared to the manual group.
Detailed description
The maintenance of MAP is essential for organ perfusion pressure. Intraoperative hypotension is a frequent complication both after induction and during maintenance of anaesthesia, ranging from 5% to 75% depending on the chosen definition. Tissue hypoperfusion exposes to the occurrence of a systemic inflammatory response syndrome and is a key determinant of postoperative complications. Persistent intraoperative hypotension has been reported as an important prognostic factor of postoperative morbidity and mortality. Adequate treatment of arterial hypotension is therefore of particular importance during surgery. However, the avoidance of hypotension includes the infusion of vasopressor and/or fluid to optimize perfusion pressure. The manual adjustment of vasopressor administration has been shown to be suboptimal.
Recently, a paper published in the JAMA journal demonstrated that among patients undergoing high-risk surgery, the maintenance of blood pressure within 10% of patient's baseline systolic blood pressure resulted in less postoperative organ dysfunction compared to standard MAP management.
Today, the investigators have an automated clinical decision support system that help ease the administration of both fluid and vasopressors during surgery (individualized fluid and vasopressor administration). The department of the investigators has recently implemented a manual hemodynamic protocol to optimize fluid and vasopressor. The goal is to maintain stroke volume index within 90% of the optimal stroke volume via mini fluid challenge of crystalloid solution (100 ml) following the French guidelines and to maintain MAP within 90 % of patient's baseline MAP. This protocol has been called : Individualized Fluid and vasopressor protocol (because based on patient's values) The purpose of this study is therefore to compare two different strategies of intraoperative mean arterial pressure (MAP) and stroke volume index management in high-risk surgical patients (manual versus automated and decision support guided) The investigators hypothesis is that automated group will spend less time during surgery in hypotension (defined as a MAP<90% of patient's MAP baseline) compared to the manual group because patient's stroke volume and MAP will be better maintained during surgery (within 10% of patient' targets).The decision support system will remind the clinician when to administer a bolus of fluid to maintain stroke volume index within 10% of the optimize stroke volume index value and an automated closed-lopp system will titrate norepinephrine to keep MAP within 10% of patient's MAP target. The study will thus compare an individualized hemodynamic protocol (already in place in our institution) applied manually to a decision support-and closed-loop guided- individualized hemodynamic protocol (intervention group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual management of hypotension | Active comparator | Device: Automated management of hypotensionFluid and vasopressor will be managed as standard practice ( manually infusion of both fluid and vasopressors) following the investigators manual individualized hemodynamic protocol.(objective being to keep both stroke volume and MAP within 90 % of the target values) |
| Automated management of hypotension | Experimental | Device: Automated management of hypotensionFluid and vasopressor will be managed with a novel active clinical decision support system to guide fluid administration and automated closed-loop system to maintain MAP within 90% of patient' baseline. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients scheduled for major abdominal and orthopedic surgery equipped with a cardiac output monitoring device.
Key exclusion criteria (3 listed)
- Patients < 18 years old
- cardiac arrythmia (atrial fibrillation)
- Pregnant woman
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 management of hypotensionFluid and vasopressor will be administered based on a novel automated clinical decision support system. | Device | Automated management of hypotension, Manual management of hypotension |
Primary outcome
Percentage of surgery time in hypotension
Time frame: at day 1
Percentage of surgery time in hypotension (defined as the percentage of case time the patient will spend with a MAP < 10% of patient's MAP Baseline)
1 secondary outcome
Postoperative complications incidence
Time frame: at DAY 30
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 2 Mar 2021.
- 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.
Alexandre Joosten, MD PhD principal investigator
Bicetre hospital, APHP.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated management of hypotension in people with Intraoperative Hypotension, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 3 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 2 Mar 2021. 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?
Percentage of surgery time in hypotension (time frame: at day 1). 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 2 Mar 2021.