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NCT05335109CompletedPhase 3

Neuroprotective Effects of Xenon Treatment in Patients with Cerebral Infarction

Neuroprotective Effects of Xenon Treatment in Patients with Cerebral Infarction: Randomized Single-blinded Placebo-controlled Trial

Source: ClinicalTrials.gov · Last updated 3 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
40 (actual)
First submitted
12 Apr 2022
Start date
1 Jan 2022
Primary completion date
15 Jan 2024
Lead sponsor
Negovsky Reanimatology Research Institute
Diseases
Stroke
NCT number
NCT05335109

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 40
  • From 1 Jan 2022 to the primary completion date, 15 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Myocardial infarction in the previous 6 months
  • Documented pneumonia within 3 months before randomization

Other illness

  • Class of chronic kidney disease ≥ 3b
  • Decompensated insulin-dependent diabetes mellitus
  • The presence of thrombolysis associated with an actual ischemic stroke

Other

  • Body mass index \> 35 kg/m2
  • NYHA class ≥ 3
  • The need for inotropic and/or vasopressor support

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
V.A. Negovsky Research Institute of General Reanimatology, Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.