Critical IllnessPhase 1/2NCT07296029
CONFOCAL-2 Interventional Pilot Study
A Phase 1/2 study testing Autoregulation-based precision blood pressure management in people with Critical Illness and Respiratory Failure, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Respiratory Failure, Shock
- What is being tested?
- Autoregulation-based precision blood pressure management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2022to 8 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2 (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.
- Conditions
- Critical Illness, Respiratory Failure, Shock, Delirium
- Being tested
- Autoregulation-based precision blood pressure management
- Keywords
- cerebral oximetry, near-infared spectroscopy, neurocognitive, post-ICU syndrome, precision medicine
- Medical subject headings
- Critical Illness, Respiratory Insufficiency, Shock, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autoregulation-based precision blood pressure managementDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Autoregulation-based precision blood pressure management | Experimental | Blood pressure maintenance based on cerebral oximetry autoregulation measurement. Receives: Drug: Autoregulation-based precision blood pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Target recruitment rate = 1 patient/month
Measured: 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
Measured: 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
Measured: for 24-72 hours after enrolment
Secondary outcomes (3)
Correlation between delirium and cerebral autoregulation
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.
Measured: Up to day 30 after ICU admission or the day of patient discharge
Correlation between delirium and time outside MAPopt
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.
Measured: Up to day 30 after ICU admission or the day of patient discharge
Exploratory short-term delirium outcomes
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.
Measured: Up to day 30 after ICU admission or the day of patient discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start29 Jul 2022
- Primary completion8 Feb 2025
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gordon Boyd, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296029
- Sponsor's protocol ID
- 6033269
- Status last verified
- Dec 2025
- First submitted
- 26 Mar 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are open to sharing individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, appendices). Data sharing would be available to interested researchers for IPD meta-analysis or other research aims for which IPD is necessary. Proposals should be directed to study contact Dr. Gordon Boyd at Gordon.Boyd@kingstonhsc.ca. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2 (CONFOCAL-2) Interventional Pilot Study
- ClinicalTrials.gov ID
- NCT07296029
- Acronym / sponsor ID
- 6033269
- Conditions
- Critical Illness, Respiratory Failure, Shock, Delirium
- Keywords
- cerebral oximetry, near-infared spectroscopy, neurocognitive, post-ICU syndrome, precision medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 8 Feb 2025 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autoregulation-based precision blood pressure management | Experimental | Drug: Autoregulation-based precision blood pressure managementBlood pressure maintenance based on cerebral oximetry autoregulation measurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to a critical care unit requiring one or more of the following:
- Presence of an arterial line
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autoregulation-based precision blood pressure managementBlood 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. | Drug | Autoregulation-based precision blood pressure management |
Primary outcome
Recruitment rate
Time frame: From period of study start to finish, an average of one year.
Target recruitment rate = 1 patient/month
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
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
3 secondary outcomes
Correlation between delirium and cerebral autoregulation
Time frame: Up to day 30 after ICU admission or the day of patient discharge
Correlation between delirium and time outside MAPopt
Time frame: Up to day 30 after ICU admission or the day of patient discharge
Exploratory short-term delirium outcomes
Time frame: Up to day 30 after ICU admission or the day of patient discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. We are open to sharing individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, appendices). Data sharing would be available to interested researchers for IPD meta-analysis or other research aims for which IPD is necessary. Proposals should be directed to study contact Dr. Gordon Boyd at Gordon.Boyd@kingstonhsc.ca. To gain access, data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autoregulation-based precision blood pressure management in people with Critical Illness and Respiratory Failure, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From period of study start to finish, an average of one year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.