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CONFOCAL-2 Interventional Pilot Study | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

CONFOCAL-2 Interventional Pilot Study

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

NCT07296029•Queen's University

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (1)

Kingston Health Sciences Center

Kingston, Ontario, Canada

Key Dates

Start Date

July 29, 2022

Primary Completion Date

February 8, 2025

Completion Date

February 8, 2025

Last Updated

December 22, 2025

Enrollment

ACTUAL participants

Conditions

Critical IllnessRespiratory FailureShockDelirium

Interventions

Autoregulation-based precision blood pressure management

DRUG

The Intensive Care Platform Trial

NCT06667999

Intensive Care PatientsIntensive Care Unit Patients+1 more

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RECRUITING

Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle

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Critical Illness

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CONFOCAL-2 Interventional Pilot Study

Inclusion Criteria

Exclusion Criteria

The Intensive Care Platform Trial

Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle

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