CONFOCAL-2 Interventional Pilot Study
Key facts
- Who runs it
- Queen's University
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 1/2
- People taking part
- 16 people enrolled
- Started
- 29 Jul 2022
- Ended
- 8 Feb 2025
- Type of study
- Interventional
- Treatments tested
- Autoregulation-based precision blood pressure management
- Record updated
- 22 December 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Primary central nervous system admitting diagnosis (e.g. traumatic brain injury, stroke, subarachnoid haemorrhage, cardiac arrest)
- Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)
- Admission to the ICU > 24 hours
- Life expectancy <24 hours
- Pregnancy
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Autoregulation-based precision blood pressure managementTreatment being tested
Blood pressure maintenance based on cerebral oximetry autoregulation measurement.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2 (CONFOCAL-2) Interventional Pilot Study
- Record updated
- 22 December 2025