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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

April 20, 2015
June 11, 2015
November 9, 2016
January 2015
July 2017   (Final data collection date for primary outcome measure)
oxygenation index [ Time Frame: perioperative period ]
  • Murray's acute lung injury score [ Time Frame: 5 min after induction of anesthesia ]
  • Murray's acute lung injury score [ Time Frame: 5 min before surgery ends ]
  • Murray's acute lung injury score [ Time Frame: 6h after surgery ]
  • Murray's acute lung injury score [ Time Frame: 12h after surgery ]
  • Murray's acute lung injury score [ Time Frame: 24h after surgery ]
  • Blood pressure [ Time Frame: 5 min after induction of anesthesia ]
  • Blood pressure [ Time Frame: 5 min before surgery ends ]
  • Blood pressure [ Time Frame: 6h after surgery ]
  • Blood pressure [ Time Frame: 12h after surgery ]
  • Blood pressure [ Time Frame: 24h after surgery ]
  • the dosage of vasoactive drugs [ Time Frame: 30 days after surgery ]
  • extubation time [ Time Frame: 30 days after surgery ]
  • ICU stay time [ Time Frame: 30 days after surgery ]
  • complications of vital organs [ Time Frame: 30 days after surgery ]
  • the duration of hospital stays [ Time Frame: 30 days after surgery ]
  • early mortality [ Time Frame: 30 days after surgery ]
Complete list of historical versions of study NCT02468531 on ClinicalTrials.gov Archive Site
  • 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 ]
  • tumor necrosis factor(TNF-α) in exhaled breath condensate [ Time Frame: 5 min after induction of anesthesia ]
  • tumor necrosis factor(TNF-α) in exhaled breath condensate [ Time Frame: 5 min before surgery ends ]
  • tumor necrosis factor(TNF-α) in exhaled breath condensate [ Time Frame: 6h after surgery ]
  • tumor necrosis factor(TNF-α) in exhaled breath condensate [ Time Frame: 12h after surgery ]
  • tumor necrosis factor(TNF-α) in exhaled breath condensate [ Time Frame: 24h after surgery ]
  • Interleukin-6(IL-6) in exhaled breath condensate [ Time Frame: 5 min after induction of anesthesia ]
  • Interleukin-6(IL-6) in exhaled breath condensate [ Time Frame: 5 min before surgery ends ]
  • Interleukin-6(IL-6) in exhaled breath condensate [ Time Frame: 6h after surgery ]
  • Interleukin-6(IL-6) in exhaled breath condensate [ Time Frame: 12h after surgery ]
  • Interleukin-6(IL-6) in exhaled breath condensate [ Time Frame: 24h after surgery ]
  • Interleukin-8(IL-8) in exhaled breath condensate [ Time Frame: 5 min after induction of anesthesia ]
  • Interleukin-8(IL-8) in exhaled breath condensate [ Time Frame: 5 min before surgery ends ]
  • Interleukin-8(IL-8) in exhaled breath condensate [ Time Frame: 6h after surgery ]
  • Interleukin-8(IL-8) in exhaled breath condensate [ Time Frame: 12h after surgery ]
  • Interleukin-8(IL-8) in exhaled breath condensate [ Time Frame: 24h after surgery ]
  • Interleukin-10(IL-10) in exhaled breath condensate [ Time Frame: 5 min after induction of anesthesia ]
  • Interleukin-10(IL-10) in exhaled breath condensate [ Time Frame: 5 min before surgery ends ]
  • Interleukin-10(IL-10) in exhaled breath condensate [ Time Frame: 6h after surgery ]
  • Interleukin-10(IL-10) in exhaled breath condensate [ Time Frame: 12h after surgery ]
  • Interleukin-10(IL-10) in exhaled breath condensate [ Time Frame: 24h after surgery ]
  • Potential Of Hydrogen(pH) of exhaled breath condensate [ Time Frame: 5 min after induction of anesthesia ]
  • Potential Of Hydrogen(pH) of exhaled breath condensate [ Time Frame: 5 min before surgery ends ]
  • Potential Of Hydrogen(pH) of exhaled breath condensate [ Time Frame: 6h after surgery ]
  • Potential Of Hydrogen(pH) of exhaled breath condensate [ Time Frame: 12h after surgery ]
  • Potential Of Hydrogen(pH) of exhaled breath condensate [ Time Frame: 24h after surgery ]
  • nitric oxide in exhaled breath condensate [ Time Frame: 5 min after induction of anesthesia, ]
  • nitric oxide in exhaled breath condensate [ Time Frame: 5 min before surgery ends ]
  • nitric oxide in exhaled breath condensate [ Time Frame: 6h after surgery ]
  • nitric oxide in exhaled breath condensate [ Time Frame: 12h after surgery ]
  • nitric oxide in exhaled breath condensate [ Time Frame: 24h after surgery ]
  • hydrogen peroxide(H2O2) in exhaled breath condensate [ Time Frame: 5 min after induction of anesthesia ]
  • hydrogen peroxide(H2O2) in exhaled breath condensate [ Time Frame: 5 min before surgery end ]
  • hydrogen peroxide(H2O2) in exhaled breath condensate [ Time Frame: 6h after surgery ]
  • hydrogen peroxide(H2O2) in exhaled breath condensate [ Time Frame: 12h after surgery ]
  • hydrogen peroxide(H2O2) in exhaled breath condensate [ Time Frame: 24h after surgery ]
  • Interleukin-6(IL-6) in Venous blood [ Time Frame: 5 min after induction of anesthesia ]
  • Interleukin-6(IL-6) in Venous blood [ Time Frame: 5 min before surgery ends ]
  • Interleukin-6(IL-6) in Venous blood [ Time Frame: 6h after surgery ]
  • Interleukin-6(IL-6) in Venous blood [ Time Frame: 12h after surgery ]
  • Interleukin-6(IL-6) in Venous blood [ Time Frame: 24h after surgery ]
  • Interleukin-8(IL-8) in Venous blood [ Time Frame: 5 min after induction of anesthesia ]
  • Interleukin-8(IL-8) in Venous blood [ Time Frame: 5 min before surgery ends ]
  • Interleukin-8(IL-8) in Venous blood [ Time Frame: 6h after surgery ]
  • Interleukin-8(IL-8) in Venous blood [ Time Frame: 12h after surgery ]
  • Interleukin-8(IL-8) in Venous blood [ Time Frame: 24h after surgery ]
  • Interleukin-10(IL-10) in Venous blood [ Time Frame: 5 min after induction of anesthesia ]
  • Interleukin-10(IL-10) in Venous blood [ Time Frame: 5 min before surgery ends ]
  • Interleukin-10(IL-10) in Venous blood [ Time Frame: 6h after surgery ]
  • Interleukin-10(IL-10) in Venous blood [ Time Frame: 12h after surgery ]
  • Interleukin-10(IL-10) in Venous blood [ Time Frame: 24h after surgery ]
  • tumor necrosis factor(TNF-α) in Venous blood [ Time Frame: 5 min after induction of anesthesia ]
  • tumor necrosis factor(TNF-α) in Venous blood [ Time Frame: 5 min before surgery ends ]
  • tumor necrosis factor(TNF-α) in Venous blood [ Time Frame: 6h after surgery ]
  • tumor necrosis factor(TNF-α) in Venous blood [ Time Frame: 12h after surgery ]
Not Provided
Not Provided
 
Xenon Against Postoperative Oxygen Impairment
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Lung Injury
  • Other: oxygen
    50% oxygen inhalation
  • Drug: Xenon
    50% Xenon inhalation
  • Oxygen group
    50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50% oxygen during CPB.
    Intervention: Other: oxygen
  • 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.
    Intervention: Drug: Xenon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
160
80
December 2017
July 2017   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02468531
2014.7-2017.7
Yes
Not Provided
Plan to Share IPD: No
WeiPing Cheng, Beijing Anzhen Hospital
Beijing Anzhen Hospital
Not Provided
Principal Investigator: Weiping Weiping Beijing Anzhen Hospital
Beijing Anzhen Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP