Intraoperative Fluid ManagementAMIGO-1NCT03477617
Advanced Monitoring to Inform and Guide Perioperative Hemodynamic Optimization 1 (AMIGO-1) Study
A study testing Intraoperative Hemodynamic Algorithm and Usual hemodynamic management in people with Intraoperative Fluid Management, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Serious complications occur in about 16% of major surgeries. Episode of hypotension during surgery may be a leading cause of these complications. Even though hypotension occurs frequently during surgery, choosing the correct treatment remains difficult in clinical practice. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Intraoperative Fluid Management
- What is being tested?
- Intraoperative Hemodynamic Algorithm and Usual hemodynamic management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 3 May 2018to 1 Sep 2019
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 years
- Abdominal, retroperitoneal, pelvic or vascular surgery requiring general anesthesia and planned postoperative stay of ≥48 hours for medical reasons
- Elevated perioperative cardiovascular risk based on at least one of the following:
- cardiovascular comorbidities: coronary artery disease, heart failure, cerebrovascular disease, or peripheral arterial disease
- elevated age (≥70 y),
- smoker,
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- hypertension,
- diabetes mellitus,
- or preoperative estimated glomerular filtration rate ≤60mL/min/1.73m2
- Planned placement of invasive arterial line for clinical care
Who cannot join
- Preoperative dialysis dependence
- Minimally invasive procedures (i.e., laparoscopic or endovascular approach)
- Intra-thoracic procedures
- Non-sinus rhythm
- Liver resection surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: A Single Centre Feasibility Randomized Controlled Trial of Advanced Minimally Invasive Monitoring to Optimize Hemodynamic Management in Major Noncardiac Surgery
Serious complications occur in about 16% of major surgeries. Episode of hypotension during surgery may be a leading cause of these complications. Even though hypotension occurs frequently during surgery, choosing the correct treatment remains difficult in clinical practice. Physicians are often uncertain as to whether low blood pressure should be treated with intravenous fluid or vasoactive drugs. The first treatment of choice typically involves administering more intravenous fluid; however, excessive fluid administration during surgery has been shown to be deleterious. New minimally invasive hemodynamic monitors now offer a potential solution by guiding physicians with respect to the choice of appropriate intervention (i.e., fluid versus vasoactive drugs). The Investigators will conduct a single-center feasibility randomized control trial (RCT) at the Toronto General Hospital (Toronto, ON, Canada) of an algorithm to manage hypotension during surgery based on the information captured by a minimally invasive monitor. Sixty participants who are aged 40 years or older and scheduled to undergo an abdominal, pelvic or vascular surgery will be randomized to have the intraoperative hypotension managed by either the new algorithm (guided by the monitor) or usual care. Participants will be recruited over 12 to 18 months, and followed for 30 days to describe differences in clinical care, hemodynamics, complications, and death. The feasibility of a future multicenter RCT will be assessed based on this present study demonstrating that (1) the algorithm can be practically implemented in a clinical setting where hemodynamic monitors are not typically used; (2) initial descriptive data suggest differences in care between groups; (3) there are no obvious major harms from the protocol; and (4) there is an acceptable participation rate among eligible patients. These data will inform any required changes to the algorithm and protocol to allow for its application in a future study.
- Conditions
- Intraoperative Fluid Management
- Being tested
- Intraoperative Hemodynamic Algorithm, Usual hemodynamic management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Hemodynamic AlgorithmOther
Anesthesiologists are instructed to use the study's algorithm to manage intraoperative hypotension in response to the cardiac output monitor values.
Usual hemodynamic managementCombination product
Anesthesiologists are instructed to manage intraoperative hypotension based on their usual clinical care, without information from cardiac output monitor
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Hemodynamic Algorithm | Experimental | In the experimental group, the anesthesiologist will have complete access to data from the minimal invasive cardiac output monitor. During the intraoperative period, the anesthesiologist will be instructed to use a hemodynamic management algorithm to manage episodes of significant hypotension Receives: Other: Intraoperative Hemodynamic Algorithm |
| Usual Hemodynamic Management | Active comparator | In the control arm, the participant will be monitored by the cardiac output monitor, but the anesthesiologists in the operating room will be blinded to hemodynamic data from the monitor. Data from the monitor will be stored electronically and used to compare hemodynamic parameters between study arms. Receives: Combination Product: Usual hemodynamic management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey score on practicality of study algorithm (Intervention)
- Practicality of study algorithm will be measured by the survey scores of the anesthesiologists involved in the intraoperative care, assessing several domains using a 5 point Likert scale such as (1) Ease of use, (2) Clinical Utility, (3) Validity
Measured: 2 years
Participation rate (Feasibility trial pre-RCT)
- Participation rate: The number of patients consented to the study over the number of eligible patients. This will help estimate recruitment rates in a future clinical randomized trial.
Measured: 2 years
Incidence of treatment related Adverse Events
Number of participants with Adverse Events thought to be at least possibly related to the study treatment will be reported. This outcome will assure that no harm has resulted from the study protocol and the protocol is safe for a future randomized control trial
Measured: 2 years
Secondary outcomes (3)
Volume of intravenous fluid and volume of blood products (therapeutic interventions) for each arm of the study.
- The volume of IV fluid and volume of blood products prescribed by the anesthesiologist will be reported as mean (in mL) separately for each study arm. Since this is a feasibility trial the statistical analysis for this study will be descriptive in nature, therefore no statistical differences will be reported between the 2 arms.
Measured: During intra-operative period and recovery, an average of 12 hours.
Dose of vasoactive medication (therapeutic interventions) for each arm of the study.
- The dose of vasoactive medications prescribed by the anesthesiologist will be reported as means (in the unit of each vasoactive medication i.e., mg, mcg, etc.) separately for each study arm. Since this is a feasibility trial the statistical analysis for this study will be descriptive in nature, therefore no statistical differences will be reported between the 2 arms.
Measured: During intra-operative period and recovery, an average of 12 hours.
Hypotension (blood pressure in mmHg) (therapeutic interventions) for each arm of the study
- Hypotension is the indication for receiving treatment in the study; therefore, blood pressure will be measured during surgery (every 5 minutes electronically by the non-invasive monitors) and after surgery (every hour by an ambulatory blood pressure monitor) separately for each study arm. Since this is a feasibility trial the statistical analysis for this study will be descriptive in nature, therefore no statistical differences will be reported between the 2 arms.
Measured: During intra-operative period and up to 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start3 May 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Fluid ManagementStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Parallel Assignment Participants are randomized to two groups; both groups will have an intraoperative minimally invasive cardiac output monitor connected. In the intervention arm, the anesthesiologist will treat episodes of hypotension using a hemodynamic algorithm based on the information for the cardiac output monitor. In the control arm, the anesthesiologist will treat episodes of hypotension using standard of care management and will be blinded to the information from the cardiac output monitor. Data from the monitor will be stored for comparison between the arms. This is a pilot study; therefore, the main objective is to assess feasibility of a future multicenter RCT, based on the following domains: (i) participation rate among eligible patients; (ii) practicality of implementing the study intervention in a clinical setting; (iii) collect descriptive data for differences between the 2 arms; (iv) collect safety data to ensure no harm has resulted from the study protocol
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Carroll, University Health Network, Toronto
- Investigators
- Duminda N Wijeysundera, Dr, Principal investigator, Universtiy Health Network. Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477617
- Sponsor's protocol ID
- 15-9764
- Acronym
- AMIGO-1
- Status last verified
- Sep 2020
- First submitted
- 26 Feb 2018
- Last updated
- 29 Sep 2020
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Feasibility Randomized Controlled Trial of Advanced Minimally Invasive Monitoring to Optimize Hemodynamic Management in Major Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT03477617
- Acronym / sponsor ID
- AMIGO-1 / 15-9764
- Conditions
- Intraoperative Fluid Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 26 Mar 2018 (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.
Serious complications occur in about 16% of major surgeries. Episode of hypotension during surgery may be a leading cause of these complications. Even though hypotension occurs frequently during surgery, choosing the correct treatment remains difficult in clinical practice. Physicians are often uncertain as to whether low blood pressure should be treated with intravenous fluid or vasoactive drugs. The first treatment of choice typically involves administering more intravenous fluid; however, excessive fluid administration during surgery has been shown to be deleterious. New minimally invasive hemodynamic monitors now offer a potential solution by guiding physicians with respect to the choice of appropriate intervention (i.e., fluid versus vasoactive drugs). The Investigators will conduct a single-center feasibility randomized control trial (RCT) at the Toronto General Hospital (Toronto, ON, Canada) of an algorithm to manage hypotension during surgery based on the information captured by a minimally invasive monitor. Sixty participants who are aged 40 years or older and scheduled to undergo an abdominal, pelvic or vascular surgery will be randomized to have the intraoperative hypotension managed by either the new algorithm (guided by the monitor) or usual care. Participants will be recruited over 12 to 18 months, and followed for 30 days to describe differences in clinical care, hemodynamics, complications, and death. The feasibility of a future multicenter RCT will be assessed based on this present study demonstrating that (1) the algorithm can be practically implemented in a clinical setting where hemodynamic monitors are not typically used; (2) initial descriptive data suggest differences in care between groups; (3) there are no obvious major harms from the protocol; and (4) there is an acceptable participation rate among eligible patients. These data will inform any required changes to the algorithm and protocol to allow for its application in a future study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Participants are randomized to two groups; both groups will have an intraoperative minimally invasive cardiac output monitor connected. In the intervention arm, the anesthesiologist will treat episodes of hypotension using a hemodynamic algorithm based on the information for the cardiac output monitor. In the control arm, the anesthesiologist will treat episodes of hypotension using standard of care management and will be blinded to the information from the cardiac output monitor. Data from the monitor will be stored for comparison between the arms. This is a pilot study; therefore, the main objective is to assess feasibility of a future multicenter RCT, based on the following domains: (i) participation rate among eligible patients; (ii) practicality of implementing the study intervention in a clinical setting; (iii) collect descriptive data for differences between the 2 arms; (iv) collect safety data to ensure no harm has resulted from the study protocol
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Hemodynamic Algorithm | Experimental | Other: Intraoperative Hemodynamic AlgorithmIn the experimental group, the anesthesiologist will have complete access to data from the minimal invasive cardiac output monitor. During the intraoperative period, the anesthesiologist will be instructed to use a hemodynamic management algorithm to manage episodes of significant hypotension |
| Usual Hemodynamic Management | Active comparator | Combination Product: Usual hemodynamic managementIn the control arm, the participant will be monitored by the cardiac output monitor, but the anesthesiologists in the operating room will be blinded to hemodynamic data from the monitor. Data from the monitor will be stored electronically and used to compare hemodynamic parameters between study arms. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥40 years
- Abdominal, retroperitoneal, pelvic or vascular surgery requiring general anesthesia and planned postoperative stay of ≥48 hours for medical reasons
- Elevated perioperative cardiovascular risk based on at least one of the following:
- Planned placement of invasive arterial line for clinical care
Key exclusion criteria (5 listed)
- Preoperative dialysis dependence
- Minimally invasive procedures (i.e., laparoscopic or endovascular approach)
- Intra-thoracic procedures
- Non-sinus rhythm
- Liver resection surgery
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 |
|---|---|---|
| Intraoperative Hemodynamic AlgorithmAnesthesiologists are instructed to use the study's algorithm to manage intraoperative hypotension in response to the cardiac output monitor values. | Other | Intraoperative Hemodynamic Algorithm |
| Usual hemodynamic managementAnesthesiologists are instructed to manage intraoperative hypotension based on their usual clinical care, without information from cardiac output monitor | Combination product | Usual Hemodynamic Management |
Primary outcome
Survey score on practicality of study algorithm (Intervention)
Time frame: 2 years
• Practicality of study algorithm will be measured by the survey scores of the anesthesiologists involved in the intraoperative care, assessing several domains using a 5 point Likert scale such as (1) Ease of use, (2) Clinical Utility, (3) Validity
Participation rate (Feasibility trial pre-RCT)
Time frame: 2 years
• Participation rate: The number of patients consented to the study over the number of eligible patients. This will help estimate recruitment rates in a future clinical randomized trial.
Incidence of treatment related Adverse Events
Time frame: 2 years
Number of participants with Adverse Events thought to be at least possibly related to the study treatment will be reported. This outcome will assure that no harm has resulted from the study protocol and the protocol is safe for a future randomized control trial
3 secondary outcomes
Volume of intravenous fluid and volume of blood products (therapeutic interventions) for each arm of the study.
Time frame: During intra-operative period and recovery, an average of 12 hours.
Dose of vasoactive medication (therapeutic interventions) for each arm of the study.
Time frame: During intra-operative period and recovery, an average of 12 hours.
Hypotension (blood pressure in mmHg) (therapeutic interventions) for each arm of the study
Time frame: During intra-operative period and up to 72 hours after surgery.
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 29 Sep 2020.
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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.
Duminda N Wijeysundera, Dr principal investigator
Universtiy Health Network. Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Hemodynamic Algorithm and Usual hemodynamic management in people with Intraoperative Fluid Management, run by University Health Network, Toronto at 1 site in Canada.
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 10 inclusion and 5 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 29 Sep 2020. 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 Canada. 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?
Survey score on practicality of study algorithm (Intervention) (time frame: 2 years). The study lists 3 primary outcomes in all. 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 29 Sep 2020.