Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness

Sepsis Clinical Trial

— CONFOCAL  

Official title:

Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344043
• Other study ID #: DMED-1662-13
• Status: Completed
• Phase: N/A
• First received: January 8, 2015
• Last updated: November 25, 2016
• Start date: March 2014
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Purpose of the Study Critical illness requiring life support affects over 150 000 people in Ontario every year. With aggressive support, the number of people who die from critical illness is decreasing. However, people who survive often have neurological problems. These neurological problems often include difficulties with memory, concentration, and attention. These problems are associated with poor quality of life among survivors of critical illness. The aim of this study is to identify the factors that contribute to these neurological deficits. Specifically, the investigators are testing whether changes in oxygen delivery to the brain during critical illness are related to both short- and long-term neurological complications.

Procedures involved in the Research When patients are diagnosed with a critical illness such as shock or respiratory failure, they are treated with intravenous fluids, medications to raise their blood pressure, and can be placed on a ventilator to assist with their breathing. They are observed in an intensive care unit (ICU). This research protocol does NOT interfere with the normal treatment of patients with critical illness. The procedure involved in this research protocol requires the placement of two stickers to either side of the patient's forehead, and information about oxygen delivery to the brain will be recorded. When the patient has recovered from the critical illness, they will be asked to perform several neurological tests. Some of these tests will be done with a pencil and paper, while others will use a robotic device to test arm movements, reaction time, and concentration.

Potential Harms, Risks or Discomforts:

This research study involves the placement of a sticker sensor to either side of the forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be removed. With regards to the neurological testing, rarely patients can have some mild muscle stiffness after moving their arms in the robot. The investigators do not expect any other further harms, risks, or discomforts.

Description:

A detailed protocol is currently under review for funding at Physician Services Incorporated, and can be included pending decision.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Critically ill patients defined as having either:

1. Respiratory failure: Defined as invasive mechanical ventilation for a predicted duration of >24 hours, or:

2. Shock: Defined as being on one of the following agents:

• norepinephrine (>5 mcg/min) IV

• epinephrine (at any dose)

• vasopressin (in combination with another pressor)

• milrinone (in combination with another pressor)

Exclusion Criteria:

• expected survival <24 hours

• history of cognitive dysfunction

• unable to participate in follow up testing

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis

Intervention

Device:
• Near infrared spectroscopy
This device uses near infrared spectroscopy to measure tissue oxygen levels (0-100%). The sensors are placed on the subjects' forehead to measure brain tissue oxygenation

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium	The CAM-ICU and ICDSC are used to screen for delirium in critically ill patients. On the basis of these two validated screening tools, patients will be categorized as either comatose, delirious, or intact. The percentage of ICU stay that the participant spends delirious is the primary outcome measure.	Proportion of ICU stay spent delirious. The average ICU stay is 7 days at our institution, however, some patients may stay much longer. We will perform delirium screening to a maximum of 30 days after ICU admission.	No
Secondary	Neurocognitive performance on KINARM tasks	The KINARM is a robotic device that provides quantitative metrics of the neurocognitive control of upper arm movements.	3 and 12 months	No
Secondary	Neurocognitive performance on the RBANS	The RBANS is the repeatable battery for the assessment of neuropsychological status	3 and 12 months	No
Secondary	Correlation between brain tissue oxygenation and physiological parameters	We will use correlation coefficients to describe the relationship between brain tissue oxygenation and physiological parameters recorded during the first 24 hours of critical illness.	First 24 hours of admission	No