CONFOCAL-2 Interventional Pilot Study

Queen's University16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Illness Respiratory Failure Shock Delirium

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Recruitment rate

Target recruitment rate = 1 patient/month

Time frame: 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

Time frame: 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

Time frame: for 24-72 hours after enrolment

Secondary Outcomes

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.

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

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.

Time frame: Up to day 30 after ICU admission or the day of patient discharge

CONFOCAL-2 Interventional Pilot Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes