Manual vs Closed-loop Control of Mean Arterial Pressure

Hypotension Clinical Trial

Official title:

Physician-Directed vs Computer-Assisted Norepinephrine Administration in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089644
• Other study ID #: P2019/347
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: March 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intraoperative hypotension can impact patient outcome. Vasopressors are usually used to correct hypotension and ensure adequate organ perfusion.

The investigators have recently developed an automated system (closed-loop system) to titrate vasopressor agents in surgical and intensive care patients.

The purpose of this study is to compare two strategies to correct hypotension based on an individual definition of hypotension (therefore, the target MAP used to define hypotension will differ for each patient (individualized approach):

1. Control group = standard practice ( manually adjusted norepinephrine infusion to correct hypotension and keep MAP within 90% of patient's baseline MAP

2. Intervention group = closed-loop (automated) vasopressor administration system will deliver norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac, Edwards Lifesciences, IRVINE, USA) to correct hypotension and keep MAP within 90% of patient's baseline MAP

Description:

In order to prevent the known postoperative complications of intraoperative hypotension, vasopressor agents are occasionally used to ensure adequate perfusion. These vasopressors are usually administered as manually adjusted infusions, but this practice requires considerable time and attention.

To overcome this issue, the investigators have developed a closed-loop vasopressor (CLV) controller to potentially correct hypotension more efficiently. After completing extensive in-silico, in-vivo studies and a pilot human trial in a small cohort of 20 patients, the investigators aimed to conduct now a randomized control trial comparing manual vasopressor adjustment versus closed-loop vasopressor adjustment in high risk patients undergoing major abdominal surgeries in order to correct hypotension during surgery

The primary outcome will be the incidence of hypotension (defined as a reduction of > 10% from patient's MAP target, or a allowed tolerance of 10% reduction from patient's baseline MAP). This has been chosen based on the recent study of Emmanuel Futier and colleagues (Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357), even if it was originally done with systolic blood pressure

Participants in both groups will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of vasopressor administration.

Fluids will be standardized in both groups and will be given as a continuous baseline infusion of 3 ml/kg/h (balanced crystalloid solution) and additional fluid boluses (mini fluid challenges of 100 ml) as a goal directed fluid therapy strategy to maintain stroke volume variation < 13%. The only difference is the way norepinephrine is delivered to the patient (manual versus closed-loop assisted)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• High-risk adult patients undergoing major abdominal surgeries requiring an advanced cardiac output monitoring device (EV1000-Edwards LifeSciences, Irvine, USA) and a tight blood pressure control

Exclusion Criteria:

• Atrial Fibrillation

• Severe Arythmia

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• closed-loop system
Hypotension will be corrected by an automated system for vasopressor administration. Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA)
• Manual adjustment
Vasopressor agents will be manually adjusted (standard practice). Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA)

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels	Brussel-hoofdstad

Sponsors (4)

Lead Sponsor	Collaborator
Erasme University Hospital	Bicetre Hospital, University of California, Irvine, University of California, Los Angeles

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of case Time in hypotension (MAP < 90% of the chosen MAP target).	Undertreatment. Percentage of time during surgery in hypotension. The MAP used to define hypotension will differ for each patient (individualized approach)	At postoperative day 1
Secondary	Percentage of case time in hypotension (MAP < 65 mmHg)	Percentage of time during surgery in hypotension using the population target usually admitted and used in clinical studies (MAP < 65 mmHg)	during surgery
Secondary	Percentage of case time in target (MAP +/- 10 mmHg) of the chosen MAP target	Percentage of time during surgery with a MAP +/- 10 mmHg of the chosen MAP target.	during surgery
Secondary	Amount of vasopressors received	Amount of vasopressors received	during surgery
Secondary	Uretral perfusion index during surgery	Mean Uretral perfusion index during surgery using the novel IKORUS urinary catheter recently available on the market	during surgery
Secondary	Uretral perfusion index during the first 15 minutes of the surgery	Mean Uretral perfusion index during the first 15 minutes of the surgery	during surgery
Secondary	Uretral perfusion index during the last 15 minutes of the surgery	Mean Uretral perfusion index during the last 15 minutes of the surgery	during surgery
Secondary	Cardiac index during surgery	Mean cardiac index during surgery	during surgery
Secondary	Stroke volume index during surgery	Mean Stroke volume index during surgery	during surgery
Secondary	Stroke volume variation during surgery	Mean Stroke volume variation during surgery	during surgery
Secondary	Amount of fluid received during surgery	Amount of fluid received during surgery	during surgery
Secondary	Net fluid balance during surgery	Net fluid balance during surgery	during surgery