Neuroprotective Effects of Xenon Treatment in Patients with Cerebral Infarction

NCT05335109 | Completed Phase 3 DMC

• 1 other identifier: NEXT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Keywords

Ischemic stroke; Xenon; Organ protection; Critical care

Outcome Measures

Primary Outcomes (1)

• National Institutes of Health Stroke Scale

  Change of scores on the National Institutes of Health Stroke Scale. Minimal score equal 0. Maximal score equal 42. Less score means better outcome.

  7 day

Secondary Outcomes (5)

• Rankin scale

  day 7

• Glasgow coma scale

  day 7

• Duration of stay in the intensive care unit

  28 days

• Nosocomial pneumonia

  28 days

• Mortality

  28 days

Study Arms (2)

Xenon

EXPERIMENTAL

Drug: Xenon

Oxygen

PLACEBO COMPARATOR

Drug: Oxygen 30 %

Interventions

Xenon DRUG

Xenon is injected into the body by inhalation in the form of xenon-oxygen mixtures, in which the concentration of xenon is 30%, and oxygen is 30%. Xenon inhalation is carried out for 30 min daily for 3 days.

Xenon

Oxygen 30 % DRUG

Oxygen-air mixture is injected into the body by inhalation. The oxygen concentration is 30%. Inhalation of oxygen-air mixture is carried out for 30 min daily for 3 days

Oxygen

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Negovsky Reanimatology Research Institute: lead

Study Sites (1)

V.A. Negovsky Research Institute of General Reanimatology, Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

Moscow, 141534, Russia

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Xenon

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Oleg Grebenchikov, MD

  Negovsky Research Reanimatology Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The head of the laboratory in the Negovsky Reanimatology Research Institute

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: January 1, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)