Acute Lung InjuryNCT02468531
Xenon Against Postoperative Oxygen Impairment
A study testing oxygen and Xenon in people with Acute Lung Injury, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- oxygen and Xenon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Weiping Cheng
About this study
Official title: 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.
- Conditions
- Acute Lung Injury
- Being tested
- oxygen, Xenon
- Keywords
- Xenon, Standford A acute aortic dissection
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenOther
50% oxygen inhalation
XenonDrug
50% Xenon inhalation
| Study group | Role | What they receive |
|---|---|---|
| Oxygen group | Other | 50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50% oxygen during CPB. Receives: Other: oxygen |
| Xenon group | Experimental | 50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50%,75% and 100% Xenon during CPB respectively. Receives: Drug: Xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation index
Measured: perioperative period
Secondary outcomes (3)
alterations in cytokine and ROS in the perioperative period
Measured: perioperative period
extubation time
Measured: perioperative period
complications of vital organs
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WeiPing Cheng, Beijing Anzhen Hospital
- Investigators
- Weiping Weiping, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468531
- Sponsor's protocol ID
- 2014.7-2017.7
- Status last verified
- Oct 2016
- First submitted
- 20 Apr 2015
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection of Xenon Against Postoperative Oxygen Impairment in Adults Undergoing Stanford Type-A Acute Aortic Dissection Surgery
- ClinicalTrials.gov ID
- NCT02468531
- Acronym / sponsor ID
- 2014.7-2017.7
- Conditions
- Acute Lung Injury
- Keywords
- Xenon, Standford A acute aortic dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen group | Other | Other: oxygen50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50% oxygen during CPB. |
| Xenon group | Experimental | Drug: Xenon50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50%,75% and 100% Xenon during CPB respectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen50% oxygen inhalation | Other | Oxygen group |
| Xenon50% Xenon inhalation | Drug | Xenon group |
Primary outcome
oxygenation index
Time frame: perioperative period
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiping Weiping principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxygen and Xenon in people with Acute Lung Injury, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiping Weiping, master ((86)010-6445-6329, ch_eng9735@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation index (time frame: perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016; AzTrials last refreshed its copy on 31 Oct 2026.