COntrolled MAp Trauma Brain Injury (COMAT Study)

Closed-Loop Communication Clinical Trial

— COMAT  

Official title:

Individualizing Mean Arterial Pressure of Head Trauma Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03792581
• Other study ID #: 2018-A02976-49
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2019
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)

Description:

In head trauma patients, the maintenance of MAP within a very narrow range is desired to avoid secondary ischemic diseases. 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 vasopressor infusion and/or fluid administration. Using a novel automated system can overcome this issue and may lead to more time in MAP target than the traditional management.

All patients will have the same automated system for fluid administration using the EV1000 monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration will be standardized in both groups. The only difference will be the management of MAP.

The goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. This treatment time should be within the first 48 hours of patient admission in the Intensive care unit.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Severe Head trauma Patients ( Glasgow score =8), intubated, ventilated and sedated

Exclusion Criteria:

• Glasgow score >8

• Bilateral mydriasis at the initial management

Related Conditions & MeSH terms

• Closed-Loop Communication

Intervention

Device:
• EV1000 and closed-loop system
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically

Locations

Country	Name	City	State
France	Joosten Alexandre	Paris	LE Kremlin Bicetre

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

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEAN ARTERIAL PRESSURE (MAP)	time when MAP will be in the predefined range (+/- 5mmHg of the predefined MAP). This target can changed over the 48 hours of patient management due to increased intracranial pressure. This target is predefined by the clinician in charge of the patient and not involved in the study.	48 hours post-admission in the intensive care
Secondary	Hypotension incidence	percentage time spent with MAP is below 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission	48 hours post-admission in the intensive care
Secondary	Hypertension incidence	percentage time spent with MAP is above 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission	48 hours post-admission in the intensive care
Secondary	Pulsatility index	measure of pulsatility index using the Transcranial doppler ultrasound	baseline (admission to the intensive care unit)
Secondary	Pulsatility index	measure of pulsatility index using the Transcranial doppler ultrasound	24 hours post-admission to the intensive care unit
Secondary	Pulsatility index	measure of pulsatility index using the Transcranial doppler ultrasound	48 hours post-admission to the intensive care unit
Secondary	Mean velocity	measure of mean velocity using the Transcranial doppler ultrasound	baseline (admission to the intensive care unit)
Secondary	Mean velocity	measure of mean velocity using the Transcranial doppler ultrasound	24 hours post-admission to the intensive care unit
Secondary	Mean velocity	measure of mean velocity using the Transcranial doppler ultrasound	48 hours post-admission to the intensive care unit
Secondary	diastolic velocity	measure of diastolic velocity using the Transcranial doppler ultrasound	baseline (admission to the intensive care unit)
Secondary	Diastolic velocity	measure of diastolic velocity using the Transcranial doppler ultrasound	24 hours post-admission to the intensive care unit
Secondary	Diastolic velocity	measure of diastolic velocity using the Transcranial doppler ultrasound	48 hours post-admission to the intensive care unit
Secondary	Fluid received	comparison of amount of fluid received during the first 48 hours post admission	48 hours post-admission in the intensive care
Secondary	Amount of vasopressor	amount of vasopressor received during the first 48 hours post admission	48 hours post-admission in the intensive care
Secondary	Length of stay in the Intensive care unit	comparison of the length of stay in the Intensive care unit between both groups	30 days post-admission in the intensive care
Secondary	Mean arterial pressure (MAP)	MAP over the first 48 hours postadmission in the intensive care	48 hours post-admission in the intensive care
Secondary	Stroke volume	stroke volume over the first 48 hours postadmission in the intensive care	48 hours post-admission in the intensive care
Secondary	cardiac index	cardiac index over the first 48 hours postadmission in the intensive care	48 hours post-admission in the intensive care