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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autoregulation-based precision blood pressure management | Experimental | Blood pressure maintenance based on cerebral oximetry autoregulation measurement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Admitted to a critical care unit requiring one or more of the following:
Presence of an arterial line
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Center | Kingston | Ontario | K7L 2V7 | Canada |
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.
Beginning 3 months and ending 5 years following article publication
Researchers who provide a methodologically sound proposal and received ethics approval for their proposal
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012131 | Respiratory Insufficiency |
| D012769 | Shock |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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|
| 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. | 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. | Up to day 30 after ICU admission or the day of patient discharge |
| D012140 | Respiratory Tract Diseases |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |