Assessment of Brain Damage Using Monitoring of Cerebral Oximetry Dynamics in Patients After Cardiac Arrest

NCT06776302 | Recruiting

• 1 other identifier: UKC Maribor OIIM/UC/KN
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sudden cardiac arrest is one of the leading causes of death in Europe. The recommended treatment for cardiac arrest is cardiopulmonary resuscitation (CPR) and electrical defibrillation with an automated external defibrillator (AED). The chain of survival, which connects all links of basic and additional resuscitation procedures and post-resuscitation care, is important for successful survival. Most patients after out-of-hospital cardiac arrest die in intensive care units due to the withdrawal of active treatment, based on the prediction of a poor neurological outcome. Prognostic indicators are influenced by many factors, including the patient's neurological condition. This should be taken into account when predicting outcome and a multimodal approach based on clinical examination, electrophysiological examinations, imaging studies and biological markers should be used. Based on the professional literature, we asked ourselves the research question of whether it is possible to achieve changes in cerebral oxygen saturation values using simple tests and whether such changes in cerebral oxygen saturation coincide with other methods used to assess neurological outcome and brain damage in patients after primary out-of-hospital cardiac arrest. The patient will have a device installed to detect cerebral oxygen saturation (NIRS) throughout the entire hospitalization period. The level of oxygen in the brain is influenced by various factors: mean arterial pressure, cardiac index, carbon dioxide level in the blood, hemoglobin level in the blood, depth of sedation, body temperature. We will attempt to achieve changes in cerebral oxygen saturation with two simple tests. The first test is based on increasing blood flow through the brain through a controlled gradual infusion of a drug that raises blood pressure. The patient will receive such an infusion immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission. The second test is based on passive elevation of the lower extremities, which results in a transient increased cardiac index produced by the heart and a consequent increase in blood flow through the brain. The second test will also be performed on the patient immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission. Based on the data obtained with the help of the aforementioned tests, we will not decide on the prognosis of the patient's neurological outcome or change or adjust the therapy in any way based on the data obtained. The aim of the study is to demonstrate that changes in cerebral oxygen saturation values in patients after primary out-of-hospital cardiac arrest, obtained with simple tests, coincide with other methods used to assess neurological outcome and brain damage.

Conditions

Cardiac Arrest (CA)

Keywords

cardiac arrest, near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• Changes in cerebral oximetry values in patients after primary out-of-hospital cardiac arrest, obtained with described tests

  From enrollment to the 2 days after admission

Study Arms (1)

Patients after cardiac arrest

EXPERIMENTAL

Patients after cardiac arrest, admited to department of Intensive internal medicine.

Diagnostic Test: Raise of blood flow through the brain

Interventions

Raise of blood flow through the brain DIAGNOSTIC_TEST

At each patient two test are preformed. The first test is based on increasing blood flow through the brain through a controlled gradual infusion of norepinephrine (noradrenalin). The patient will receive such an infusion immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission. The second test is based on passive elevation of the lower extremities. The second test will also be performed on the patient immediately upon admission and stabilization in the Department of Intensive Internal Medicine and then in the period of 6, 12, 24, 48 and 72 hours after admission.

Patients after cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Primary out-of-hospital cardiac arrest
• Unconsciousness after return of spontaneous circulation (8 points or less on the Glasgow Coma Scale)

You may not qualify if:

• Intracranial hemorrhage (clinically suspected or proven by CT scan)
• Hypothermia (body temperature less than 32 degrees Celsius)
• Pregnancy
• Uncontrollable bleeding
• Uncontrollable blood pressure fluctuations
• Patient defined as palliative or terminal
• Cardiac arrest secondary to drowning, hypothermia, or trauma

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (1)

University clinical center Maribor

Maribor, 2000, Slovenia

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Rok Petrovčič, MD

CONTACT

+38631215650; rok.5rovcic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 30, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

SL (1)