CONFOCAL-2 Interventional Pilot Study

NCT07296029 | Completed Phase 1

• 1 other identifier: 6033269
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Respiratory Failure; Shock; Delirium

Keywords

cerebral oximetry; near-infared spectroscopy; neurocognitive; post-ICU syndrome; precision medicine

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Target recruitment rate = 1 patient/month

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

• Determine optimal mean arterial pressure target (MAPopt)

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

  For 24 hours after enrollment

• Maintain MAP within MAPopt range

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

  for 24-72 hours after enrolment

Secondary Outcomes (3)

• Correlation between delirium and cerebral autoregulation

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

• Correlation between delirium and time outside MAPopt

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

• Exploratory short-term delirium outcomes

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

Study Arms (1)

Autoregulation-based precision blood pressure management

EXPERIMENTAL

Blood pressure maintenance based on cerebral oximetry autoregulation measurement.

Drug: Autoregulation-based precision blood pressure management

Interventions

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.

Autoregulation-based precision blood pressure management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston Health Sciences Center

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency; Shock; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: December 22, 2025
• Study Start: July 29, 2022
• Primary Completion: February 8, 2025
• Study Completion: February 8, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal and received ethics approval for their proposal

Locations

CA (1)