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Clinical Trials/NCT04586218
NCT04586218
Completed
Not Applicable

Postoperative Hypotension Management With Computer-guided Vasopressor Titration in High-Risk Patients After Cardiac Surgery: A Randomized Controlled Trial

Clinique de la Sauvegarde1 site in 1 country40 target enrollmentNovember 26, 2020
ConditionsCardiac Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
Clinique de la Sauvegarde
Enrollment
40
Locations
1
Primary Endpoint
incidence of postoperative hypotension
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The investigators have developed an automated vasopressor controller to improve the titration of vasopressor in order to maintain mean arterial pressure (MAP) within a narrow range and have recently shown the controller was effective in both the operating room and intensive care unit. The controller has been used recently in a case series of three patients undergoing cardiac surgery and in five patients after cardiac surgery.

The investigators want to compare now a manual to a closed-loop titration of vasopressor infusion in patients admitted in the Intensive Care unit after cardiac surgery

Detailed Description

Perioperative hypotension and arterial pressure variability have been shown to negatively impact patient outcomes, increasing risk of stroke, kidney injury, and myocardial injury among others. Vasopressors are usually used to rapidly correct hypotension. Vasopressor infusions are typically administered by standard infusion pump with the rate adjusted by anesthesiologists to reach a predefined target mean arterial pressure (MAP); this requires frequent changes in the infusion rate because of the almost constantly changing hemodynamic status of such patients. Because it is infeasible for human providers to pay constant attention and make second-to-second changes, management is often suboptimal (i.e. large amounts of time are spent in hypotension below the target, or well above the target with the vasopressor drip still running). The investigators have developed an automated closed-loop vasopressor (CLV) controller to improve the titration of vasopressor (e.g:noradrenaline) in order to maintain MAP within a narrow range in the perioperative setting. The investigators have published engineering, animal and most recently, pilot,studies or case series with promising results. In this randomized controlled trial, the investigators will compare time spent in hypotension defined as a mean arterial pressure \< 65 mmHg. They tested the hypothesis that the automated system will allow patients to spent less time during the postoperative period with a MAP \< 65 mmHg. This is thus a superiority study over a two hours study period

Registry
clinicaltrials.gov
Start Date
November 26, 2020
End Date
December 17, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patient
  • Elective cardiac surgery
  • French speaking patient

Exclusion Criteria

  • Uncontrolled hypertension
  • Renal insufficiency (estimated glomerular filtration rate \< 30mL/min/1,73m²)
  • Left ejection fraction \< 40%
  • Emergency surgery
  • Preoperative infection
  • Preoperative cardiac arrythmia
  • Pregnant women

Outcomes

Primary Outcomes

incidence of postoperative hypotension

Time Frame: postoperative hour 2

Percentage of treatment period spent with a MAP \< 65 mmHg

Secondary Outcomes

  • amount of fluid(postoperative hour 2)
  • Number of vasopressor infusion rate modifications(postoperative hour 2)
  • Amount of vasopressor(postoperative hour 2)
  • incidence of acute kidney injury(postoperative day 7)
  • troponin values(postoperative day 1)

Study Sites (1)

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