Xenon Against Postoperative Oxygen Impairment

November 8, 2016 updated by: WeiPing Cheng, Beijing Anzhen Hospital

Protection of Xenon Against Postoperative Oxygen Impairment in Adults Undergoing Stanford Type-A Acute Aortic Dissection Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
          • Weiping Cheng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oxygenation index
Time Frame: perioperative period
perioperative period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Investigators

  • Principal Investigator: Weiping Weiping, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Estimate)

November 9, 2016

Last Update Submitted That Met QC Criteria

November 8, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.7-2017.7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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