Controlled Mean Arterial Pressure of Brain Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial in Critically Ill Patients in the Intensive Care Unit
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injuries
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Mean arterial pressure (MAP)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed without any automated system (manually management)
Detailed Description
In brain injury patients, the maintenance of MAP within a very narrow range is desired to avoid complications related to hypoperfusion (undertreatment) or hypertension (over treatment). However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust drugs infusions. Using a novel automated system can overcome this issue and may lead to more time in MAP target (+/- 5mmHg) than the traditional management. After initial rescuscitation of the patients, patients in both groups will have the same baseline maintenance fluid administration of 1-2 ml/kg/h of crystalloid solution and additionnal fluid boluses administered following the EV1000 monitoring device. The only difference will be the management of vasopressor titration (manual by nurses vs automated via a closed-loop system)
Investigators
Eligibility Criteria
Inclusion Criteria
- •severe brain injury patients (Glasgow score \<9), intubated, ventilated and sedated.
Exclusion Criteria
- •Glasgow score \> 8
- •Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)
Outcomes
Primary Outcomes
Mean arterial pressure (MAP)
Time Frame: 48 hours post-admission in the intensive care unit
percentage of treatment time when MAP will be in the predefined range (+/- 5 mmHg of the target MAP)
Secondary Outcomes
- Percentage of case time spent in Hypotension(48 hours post-admission in the intensive care unit)
- stroke volume(48 hours post-admission in the intensive care unit)
- cardiac index(48 hours post-admission in the intensive care unit)
- Transcranial doppler(48 hours post-admission in the intensive care unit)
- Fluid received(48 hours post-admission in the intensive care unit)
- Percentage of case time spent Hypertension(48 hours post-admission in the intensive care unit)
- Cerebral perfusion pressure(48 hours post-admission in the intensive care unit)
- Intracranial pressure Hypertension(48 hours post-admission in the intensive care unit)
- Intracranial pressure(48 hours post-admission in the intensive care unit)
- mean arterial pressure (MAP)(48 hours post-admission in the intensive care unit)
- Amount of vasopressor(48 hours post-admission in the intensive care unit)
- Length of stay in the intensive care unit(30 days post-admission in the intensive care unit)