Overview

Condition acute lung injury
Treatments oxygen, xenon
Sponsor Beijing Anzhen Hospital
Start date January 2015
End date July 2017
Trial size 160 participants
Trial identifier NCT02468531, 2014.7-2017.7

Summary

Acute lung injury (ALI) is the vital complication of Stanford type A aortic dissection. It is confirmed that Xenon has the significant protective effect on important organs and has no suppression on the cardiovascular system. Furthermore, our earlier trial has already clarified that static inflation with 50% Xenon during cardiopulmonary bypass could attenuate ALI for Standford A acute aortic dissection. However the protection effect was restricted for the limited time. Aimed to enhance the protection effect of Xenon, we designed this randomized trial that anesthesia with 50% xenon one hour before and after CPB and pulmonary static Inflation with 50%,75% and 100% Xenon during CPB respectively.

Recruiting in the following locations…

United States No locations recruiting
Other Countries China

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Other)
50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50% oxygen during CPB.
oxygen
50% oxygen inhalation
(Experimental)
50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50%,75% and 100% Xenon during CPB respectively.
xenon
50% Xenon inhalation

Primary Outcomes

Measure
oxygenation index
time frame: perioperative period

Secondary Outcomes

Measure
alterations in cytokine and ROS in the perioperative period
time frame: perioperative period
extubation time
time frame: perioperative period
complications of vital organs
time frame: perioperative period

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria Consultant's clinical diagnosis of Stanford type A AAD using local pathways of diagnosis, which may include clinical history, chest radiography (X-rays), transthoracic ultrasound, and contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) Patients aged 18 to 65 years Eligible for AAD surgery Exclusion Criteria Have coronary heart disease, heart failure, severe cardiac tamponade, unstable hemodynamics, severe nervous system abnormalities, clinically apparent malperfusion[9] including lower limb, cerebral, coronary and renal malperfusion, and visceral ischemia, sever hepatic and renal abnormalities Have undergone any of the cardiac and thoracic surgeries Are unlikely to be able to perform the required clinical assessment tasks Have significant cognitive impairment or language issues Are unable to provide consent with regard to their participation in the study Prescribed with non-steroidal anti-inflammatory drugs or corticosteroids before or after admission

Additional Information

Official title Protection of Xenon Against Postoperative Oxygen Impairment in Adults Undergoing Stanford Type-A Acute Aortic Dissection Surgery
Principal investigator Weiping Weiping
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Beijing Anzhen Hospital.