Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring

NCT04111055 | Completed

• 1 other identifier: P2018-276
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative hypotension and blood pressure variability are associated with postoperative complications in surgical patients. The investigators have developed a closed-loop vasopressor (CLV) controller that titrates norepinephrine to correct hypotension. After having tested the system in a small cohort series of patients undergoing major surgeries, the investigators aimed to test the feasibility of the CLV controller guided noninvasively and continuously with the ClearSight system (Edwards Lifesciences, USA) in three high risk patients undergoing renal transplant surgery

Conditions

Hemodynamic (MAP) Stability

Outcome Measures

Primary Outcomes (1)

• Percentage of case time in hypotension

  % of case time without hypotension. MAP of at least 5mmHg below the chosen CLV target

  during surgery

Secondary Outcomes (3)

• Percentage of active treatment time spent in a hypertensive state

  during surgery

• Amount of vasopressor used

  during surgery

• Incidence of acute kidney injury

  30 days postsurgery

Study Arms (1)

Closed-loop group

EXPERIMENTAL

The MAP of the patient will be managed by the CLV system to avoid hypotension. The MAP target selected in the closed-loop system will be the patient's MAP target ( same target as patient's MAP value preoperatively). Then the closed-loop system will have to adjust norepinephrine infusion rate to keep that MAP value within 10% of patient's target.

Device: Closed-loop system

Interventions

Closed-loop system DEVICE

the CLV system will correct hypotension by automated adjustment of norepinephrine.

Closed-loop group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult high risk patients undergoing renal transplant surgery
• Patients equipped with a clearsight advanced hemodynamic monitoring system

You may not qualify if:

• Atrial fibrillation
• No consent obtained from the patient.
• Ejection fraction \< 30%

Sponsors & Collaborators

• Erasme University Hospital: lead
• University of California, Los Angeles: collaborator
• University of California, Irvine: collaborator

Study Sites (1)

Erasme

Brussels, 1070, Belgium

Location

Study Officials

• Alexandre J Joosten, MD PhD

  ERASME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single prospective pilot study

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 1, 2019
• Study Start: June 15, 2018
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)