CONFOCAL-2 Interventional Pilot Study

Queen's University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Delirium; Shock; Respiratory Failure; Critical Illness

Treatments: Drug: Autoregulation-based precision blood pressure management

Study type: Interventional

Funder types: Other

Identifiers

NCT07296029

6033269

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Autoregulation-based precision blood pressure management

Experimental group

Description:

Blood pressure maintenance based on cerebral oximetry autoregulation measurement.

Treatment:

Drug: Autoregulation-based precision blood pressure management