Critical Illness, Delirium, Respiratory Failure, Shock
Conditions
Keywords
cerebral oximetry, near-infared spectroscopy, neurocognitive, post-ICU syndrome, precision medicine
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.
Interventions
DRUGAutoregulation-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.
Sponsors
Queen's University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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) | For 24 hours after enrollment | Aim to determine MAPopt in \>75% of patients within the first 24 hours |
| Maintain MAP within MAPopt range | for 24-72 hours after enrolment | Aim to maintain patients in MAPopt range for \>90% of the time for 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between delirium and cerebral autoregulation | Up to day 30 after ICU admission or the day of patient discharge | 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. |
| Correlation between delirium and time outside MAPopt | Up to day 30 after ICU admission or the day of patient discharge | 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. |
| Exploratory short-term delirium outcomes | Up to day 30 after ICU admission or the day of patient discharge | 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. |
Countries
Canada
Outcome results
None listed