NCT02468531

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 9, 2016

Status Verified

October 1, 2016

Enrollment Period

2.5 years

First QC Date

April 20, 2015

Last Update Submit

November 8, 2016

Conditions

Acute Lung Injury

Keywords

XenonStandford A acute aortic dissection

Outcome Measures

Primary Outcomes (1)

  • oxygenation index

    perioperative period

Secondary Outcomes (3)

  • alterations in cytokine and ROS in the perioperative period

    perioperative period

  • extubation time

    perioperative period

  • complications of vital organs

    perioperative period

Study Arms (2)

Oxygen group

OTHER

50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50% oxygen during CPB.

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.

Drug: Xenon

Interventions

oxygenOTHER

50% oxygen inhalation

Oxygen group
XenonDRUG

50% Xenon inhalation

Xenon group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Interventions

OxygenXenon

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesNoble Gases

Study Officials

  • Weiping Weiping

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiping Weiping, master

CONTACT

(86)010-6445-6329ch_eng9735@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician, professor

Study Record Dates

First Submitted

April 20, 2015

First Posted

June 11, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

November 9, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)