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Completed

NCT Number: NCT03477617

Advanced Monitoring to Inform and Guide Perioperative Hemodynamic Optimization 1 (AMIGO-1) Study

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.

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Key information

Conditions

Intraoperative Fluid Management

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative Hemodynamic Algorithm

Other

Anesthesiologists are instructed to use the study's algorithm to manage intraoperative hypotension in response to the cardiac output monitor values.

Usual hemodynamic management

Combination Product

Anesthesiologists are instructed to manage intraoperative hypotension based on their usual clinical care, without information from cardiac output monitor

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

    • 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.

  2. 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.

    • 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.

  3. 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.

    • 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

A Single Centre Feasibility Randomized Controlled Trial of Advanced Minimally Invasive Monitoring to Optimize Hemodynamic Management in Major Noncardiac Surgery

Acronym: AMIGO-1

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2018
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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