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CONFOCAL-2 Interventional Pilot Study

NCT ID: NCT07296029

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-29

Study Completion Date

2025-02-08

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness Respiratory Failure Shock Delirium

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autoregulation-based precision blood pressure management

Blood pressure maintenance based on cerebral oximetry autoregulation measurement.

Group Type EXPERIMENTAL

Autoregulation-based precision blood pressure management

Intervention Type 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.

Interventions

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Autoregulation-based precision blood pressure management

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Admitted to a critical care unit requiring one or more of the following:

1. Respiratory failure requiring invasive mechanical ventilation with an expected duration \>24 hours or
2. 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)
2. Presence of an arterial line

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gordon Boyd

Clinician-Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kingston Health Sciences Center

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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6033269

Identifier Type: -

Identifier Source: org_study_id