Neuroprotective Effects of Xenon Treatment in Patients With Cerebral Infarction

• Status: Not yet recruiting
• Trial end date: 2024-05-29
• Target enrollment: 0
• Participant gender: All

Summary

In the Russian Federation, ischemic cerebral infarction is recorded annually in more than 450,000 people. It is the second most common cause of death after coronary heart disease.

The 30-day mortality rate after an ischemic cerebral infarction is more than 25%, and during the following year about half of the patients die. To date, all candidate neuroprotective drugs tested in various clinical trials have demonstrated insufficient efficacy . Therefore, the development of new approaches to the treatment of severe brain injuries of various etiologies is one of the most important tasks of critical condition medicine.

Brain damage due to stroke triggers a number of pathophysiological reactions, which are based on the accumulation of glutamate with the development of excitotoxicity. The effect of glutamate on NMDA receptors is one of the main factors of neurodegenerative disorders.

Xenon is an anesthetic whose neuroprotective properties have been shown in many experimental studies. Хenon inhalation after ischemia and reperfusion suppresses ischemic brain damage and tPA-induced cerebral hemorrhages, and damage to the blood-brain barrier.

The most interesting is a randomized controlled trial performed by R. Laitio et al. (2016), in which the use of xenon in combination with hypothermia in clinical practice was studied for the first time. In patients who have undergone community-acquired cardiac arrest, xenon inhalation at a concentration of 40 vol.% within 24 hours in combination with hypothermia, led to less damage to the white matter of the brain than with patients using hypothermia alone. The 6-month mortality rate was 27% in the xenon and hypothermia group and 35% in the hypothermia group.

It is important to note that today, despite a large pool of convincing preclinical studies proving the neuroprotective properties of xenon, there is not a single clinical study of its use in ischemic stroke.

Therefore, the research objectives is to determine whether the strategy of using xenon-oxygen mixture inhalation is better than oxygen-air mixture inhalation with respect to the change in scores on the NIHSS, Rankin and Glasgow coma scales on day 7, the duration of stay in the ICU and the frequency of nosocomial pneumonia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Negovsky Reanimatology Research Institute
• Treatments: Xenon

Criteria

Inclusion Criteria:

• Age > 18;

• Ischemic stroke with a NIHSS score at the time of hospitalization from 5 to 15 points

• Score on the Glasgow coma scale ≥ 13 points

• Assessment of the patient no later than 8 hours after the appearance of the first signs of ONMC

• Signed voluntary informed consent to participate in the study.

Exclusion Criteria:

• Myocardial infarction in the previous 6 months

• Body mass index > 35 kg/m2

• Class of chronic kidney disease ≥ 3b

• NYHA class ≥ 3

• Decompensated insulin-dependent diabetes mellitus

• The need for inotropic and/or vasopressor support

• The presence of thrombolysis associated with an actual ischemic stroke

• Documented pneumonia within 3 months before randomization