CONFOCAL-2 Interventional Pilot Study (NCT07296029) | Clinical Trial Compass
CompletedPhase 1/2
CONFOCAL-2 Interventional Pilot Study
Canada16 participantsStarted 2022-07-29
Plain-language summary
This study is designed to assess the feasibility of identifying and administering individualized blood pressure targets early critical illness. Recent literature suggests that individualized targets adapted to cerebral perfusion and autoregulation capacity may improve patient outcomes. In this study, cerebral autoregulation capacity is assessed by simultaneous trending of near-infared spectroscopy and arterial blood pressure for 24 hours, within patients' first 2 days in the ICU. The investigators will assess the feasibility of identifying patients' personal targets, then treating patients according to their personal targets for 48 hours. Clinical outcomes explored will include delirium.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Admitted to a critical care unit requiring one or more of the following:
. Respiratory failure requiring invasive mechanical ventilation with an expected duration \>24 hours or
. Shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: i. Dopamine ≥7.5 mcg/kg/min, ii. Dobutamine ≥5 mcg/kg/min, iii. Norepinephrine ≥5 mcg/min, iv. Phenylephrine ≥75 mcg/min, v. Epinephrine at any dose, vi. Milrinone at any dose (if used in conjunction with another agent), vii. Vasopressin ≥0.03 u/min (if used in conjunction with another agent)
. Presence of an arterial line
Exclusion criteria
. Admission to the ICU \> 24 hours
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has already been completed — does that mean the results are available, and if so, what did they find about the best blood pressure targets for critically ill patients?
2Since this was a Phase 1/Phase 2 pilot study focused partly on whether enough patients could even be enrolled, does that mean it wasn't large enough to prove this approach is safe or effective yet, and should I be looking at what comes next?
3The trial tried to personalize blood pressure targets for each patient using something called 'MAPopt' — how is that different from the standard blood pressure management I would receive in the ICU right now, and is that standard approach already an option for me?
4This study covered several serious conditions at once — critical illness, respiratory failure, shock, and delirium — so how would my doctor decide whether findings from this trial are relevant to my specific situation?
5Since recruitment is the main thing this pilot was measuring, does that mean the main goal was really just to test whether a bigger trial is possible, rather than to directly improve patient outcomes — and is there a larger follow-up trial I should be asking about instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment rate
Timeframe: From period of study start to finish, an average of one year.
2
Determine optimal mean arterial pressure target (MAPopt)