Clinical trial NCT03477617: Advanced Monitoring to Inform and Guide Perioperative Hemodynamic Optimization 1 (AMIGO-1) Study
Official title: A Single Centre Feasibility Randomized Controlled Trial of Advanced Minimally Invasive Monitoring to Optimize Hemodynamic Management in Major Noncardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Fluid Management
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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,
  * hypertension,
  * diabetes mellitus,
  * or preoperative estimated glomerular filtration rate ≤60mL/min/1.73m2
* Planned placement of invasive arterial line for clinical care

Exclusion Criteria:

* Preoperative dialysis dependence
* Minimally invasive procedures (i.e., laparoscopic or endovascular approach)
* Intra-thoracic procedures
* Non-sinus rhythm
* Liver resection surgery

Primary outcomes:
measure: Survey score on practicality of study algorithm (Intervention)
timeFrame: 2 years
measure: Participation rate (Feasibility trial pre-RCT)
timeFrame: 2 years
measure: Incidence of treatment related Adverse Events
timeFrame: 2 years
Secondary outcomes:
measure: Volume of intravenous fluid and volume of blood products (therapeutic interventions) for each arm of the study.
timeFrame: During intra-operative period and recovery, an average of 12 hours.
measure: Dose of vasoactive medication (therapeutic interventions) for each arm of the study.
timeFrame: During intra-operative period and recovery, an average of 12 hours.
measure: Hypotension (blood pressure in mmHg) (therapeutic interventions) for each arm of the study
timeFrame: During intra-operative period and up to 72 hours after surgery.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: Universtiy Health Network. Toronto General Hospital
name: Duminda N Wijeysundera, Dr
role: PRINCIPAL_INVESTIGATOR
References: