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 range18 Years

SexALL

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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
✕. Life expectancy \<24 hours
✕. Primary central nervous system admitting diagnosis (e.g. traumatic brain injury, stroke, subarachnoid haemorrhage, cardiac arrest).
✕. Pregnancy
✕. Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)

What they're measuring

Recruitment rate

Timeframe: From period of study start to finish, an average of one year.

Determine optimal mean arterial pressure target (MAPopt)

Timeframe: For 24 hours after enrollment

Maintain MAP within MAPopt range

Timeframe: for 24-72 hours after enrolment

Trial details

NCT IDNCT07296029

SponsorQueen's University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-08

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