ROS in TBI Patients in Relation to Level of Oxygenation. (ROS-TBI)

Formation of Reactive Oxygen Species in Patients With Severe Traumatic Brain Injury in Normal vs Increased Oxygenation.

This project an observational study performed on patients with severe Traumatic Brain Injury (TBI) treated at Neurosurgical ICU (NICU) at Karolinska University Hospital. The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species (ROS) in patients with severe traumatic brain injury (TBI). The patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage (Codman), microdialysis (MD), and Licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue (pBtO2). Intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure (CPP), oxygenation, dosage of vasoactive drugs etc. Despite the technical possibilities to monitor all these physiological parameters, there are no clear guidelines how to interpret the MD and pBtO2 data and implement it in clinical decision making. One of the controversies deals with optimization of oxygen levels: some authors point out the importance of adequate brain tissue oxygenation, whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ROS or facilitating pulmonary atelectasis, contributing to adverse outcome.

The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients.

This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions (normal atmospheric pressure).

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Oxygenation vs ROS Formation in TBI Patients

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital
    • Contact: Michael Nekludov, MD PhD; Email: michael.nekludov@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe isolated TBI with established intracranial monitoring (based on clinical desision), inclusion between 0 to four Days from their injury.

Description

Inclusion Criteria:

1. Severe isolated TBI (GCS<8, AIS =<3), CT-verified TBI (tSDH,tEDH, tSAH, contusion bleedings) caused by blunt or penetrating trauma.
2. Established intracranial monitoring (ICP, MD, LiCox pBtO2) at NICU.
3. Age >= 18
4. Time from trauma from 0 to 4 days.
5. Informed consent from Close relative.
6. Systemic hyperoxygenation can be used in patients with pBtO2 <20 mmHg, based on clinical decision.

Exclusion Criteria:

1. Major extracranial injury, AIS >3
2. Brain dead or expected survival <24 hours
3. Pregnancy
4. Respiratory insufficiency FiO2> 40%

6. No consent from relative.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROS concentrations in blood	ROS concentrations in patient´s blood will be measured repeatedly at normal systemic oxygenation and at increased oxygenation if necessary.	7 days
Markers of oxidative stress	Indirect markers of oxydative stress, as MDA (Malondialdehyde) and Isoprostane F2, in relation to level of systemic oxygenation.	7 days

Collaborators and Investigators

• Sponsor: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: TBI, ROS, oxygenation, cerebral monitoring, neurointensive care
• Other Study ID Numbers: K2020-1148

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No