Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We did not want to start a case series as we already finished a RCT...SO this study is now outdated
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (EV1000 Monitor) from Edwards Lifesciences (IRVINE, USA) in critically ill patients
In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) < 72mmHg) during a two hours study protocol in critically ill patients.
The target MAP will be set at 80 mmHg, and the definition of hypotension is a MAP < 90% of MAP target ( 80 mmHg - 10% = 72 mmHg)
The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.
The investigators will test the system in a short series of 10-12 critically ill patients in the ICU setting during a two hours study protocol.
Participants will receive standard patient care
Fluids will be given as a baseline crystalloid administration set at 1-2 ml/kg/h
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-loop | Experimental | Closed-loop administration of norepinephrine in critically ill patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop | Device | The system will be tested to see if it can avoid hypotension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of case Time in hypotension (MAP <72 mmHg) | The primary outcome will be the percentage of case time in predefined MAP target | During thetwo hours study protocol |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of case time with MAP >88 mmHg with norepinephrine still running | overtreatment | During the two hours study protocol |
| Amount of vasopressors received | Amount of vasopressors received (norepinephrine) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexandre Joosten, MD PhD | ERASME | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Single prospective single center study
Not provided
Not provided
Not provided
Not provided
| During the two hours study protocol |