CPPopt Guided Therapy: Assessment of Target Effectiveness

Phase 2

Completed

• Conditions: severe traumatic brain injury (TBI); severe cerebral contusion; 10021666

• Registration Number: NL-OMON47355
• Lead Sponsor: Intensive Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Any adult severe TBI patient requiring ICP monitoring and ICP/CPP directed therapy for at least 24 hrs on the assessment of the recruiting team
- Start randomization within 24 hrs after ICU admission

Exclusion Criteria

- Patients < 18 years old.
- Known pregnancy.
- Moribund at presentation (e.g. bilaterally absent pupillary responses)
- Patients with a primary decompressive craniectomy.
- Patients already enrolled in one other intervention research study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of monitoring time with measured CPP within 5 mmHg of calculated<br /><br>individual and flexible CPP (CPPopt).<br /><br>Time Frame: First 5 days during intensive care unit admission<br /><br><br /><br>In pilot studies, we showed that, on average, patients spent a mean (+SD) of<br /><br>30% (8%) of their monitored time with measured CPP within 5 mmHg of CPPopt. The<br /><br>study will be powered to target an increase in this metric to 50% of monitored<br /><br>time.</p><br>