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NCT Number: NCT07296029

CONFOCAL-2 Interventional Pilot Study

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.

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Key information

Conditions

Critical Illness Confusion Delirium Disease Attributes Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Shock Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kingston Health Sciences Center

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Autoregulation-based precision blood pressure management

Drug

Blood pressure maintenance based on cerebral oximetry autoregulation measurement. Blood pressure is raised or lowered via norepinephrine (dose range 1-10 mcg/min) and labetalol (dose range 0-2 mg/min), respectively, to match the researched blood pressure targets.

Primary outcomes

  1. Recruitment rate

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

    Target recruitment rate = 1 patient/month

  2. Determine optimal mean arterial pressure target (MAPopt)

    Time frame: For 24 hours after enrollment

    Aim to determine MAPopt in >75% of patients within the first 24 hours

  3. Maintain MAP within MAPopt range

    Time frame: for 24-72 hours after enrolment

    Aim to maintain patients in MAPopt range for >90% of the time for 48 hours

Secondary outcomes

  1. Correlation between delirium and cerebral autoregulation

    Time frame: Up to day 30 after ICU admission or the day of patient discharge

    Patients will be assessed daily for delirium throughout their entire hospital stay (ICU and ward; up to day 30) using a validated screening tool; the Confusion Assessment Method (CAM)-ICU while in ICU, and the Confusion Assessment Method (CAM) while on the ward. Trained researchers will administer the CAM-ICU once daily, at a time that is convenient for the patient, their family, and the medical team directing their care. The ICU discharge day will be considered to be the day that the attending writes orders to discharge to avoid the influence of delayed ICU discharge because of the lack of ward beds. We will calculate the correlation between the proportion of time spent with dysfunctional cerebral autoregulation and the duration of time with delirium.

  2. Correlation between delirium and time outside MAPopt

    Time frame: Up to day 30 after ICU admission or the day of patient discharge

    Patients will be assessed daily for delirium throughout their entire hospital stay (ICU and ward; up to day 30) using a validated screening tool; the Confusion Assessment Method (CAM)-ICU while in ICU, and the Confusion Assessment Method (CAM) while on the ward. Trained researchers will administer the CAM-ICU once daily, at a time that is convenient for the patient, their family, and the medical team directing their care. The ICU discharge day will be considered to be the day that the attending writes orders to discharge to avoid the influence of delayed ICU discharge because of the lack of ward beds. We will calculate the correlation between the proportion of time spent with dysfunctional cerebral autoregulation and the duration of time with delirium.

  3. Exploratory short-term delirium outcomes

    Time frame: Up to day 30 after ICU admission or the day of patient discharge

    Patients will be assessed daily for delirium throughout their entire hospital stay (ICU and ward; up to day 30) using a validated screening tool; the Confusion Assessment Method (CAM)-ICU while in ICU, and the Confusion Assessment Method (CAM) while on the ward. Trained researchers will administer the CAM-ICU once daily, at a time that is convenient for the patient, their family, and the medical team directing their care. The ICU discharge day will be considered to be the day that the attending writes orders to discharge to avoid the influence of delayed ICU discharge because of the lack of ward beds. We will calculate the correlation between the proportion of time spent with outside of MAPopt and the duration of time with delirium.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2 (CONFOCAL-2) Interventional Pilot Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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