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Xenon Against Postoperative Oxygen Impairment

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ClinicalTrials.gov Identifier: NCT02468531
Recruitment Status : Unknown
Verified October 2016 by WeiPing Cheng, Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : June 11, 2015
Last Update Posted : November 9, 2016
Sponsor:
Information provided by (Responsible Party):
WeiPing Cheng, Beijing Anzhen Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Lung Injury Other: oxygen Drug: Xenon Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protection of Xenon Against Postoperative Oxygen Impairment in Adults Undergoing Stanford Type-A Acute Aortic Dissection Surgery
Study Start Date : January 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Oxygen group
50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50% oxygen during CPB.
Other: oxygen
50% oxygen inhalation

Experimental: Xenon group
50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50%,75% and 100% Xenon during CPB respectively.
Drug: Xenon
50% Xenon inhalation




Primary Outcome Measures :
  1. oxygenation index [ Time Frame: perioperative period ]

Secondary Outcome Measures :
  1. alterations in cytokine and ROS in the perioperative period [ Time Frame: perioperative period ]
  2. extubation time [ Time Frame: perioperative period ]
  3. complications of vital organs [ Time Frame: perioperative period ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468531


Contacts
Contact: Weiping Weiping, master (86)010-6445-6329 ch_eng9735@sina.com

Locations
China, Beijing
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Weiping Cheng         
Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
Principal Investigator: Weiping Weiping Beijing Anzhen Hospital

Responsible Party: WeiPing Cheng, Chief physician, professor, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT02468531     History of Changes
Other Study ID Numbers: 2014.7-2017.7
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by WeiPing Cheng, Beijing Anzhen Hospital:
Xenon
Standford A acute aortic dissection

Additional relevant MeSH terms:
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs