AzTrials
AzTrials

Aortic DissectionNCT02774096

Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair

A study testing xenon in people with Aortic Dissection, run by Beijing Anzhen Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

With more and more people developing hypertension and atherosclerosis, the morbidity rate of Acute Aortic Dissection（AAD） has been increasing. Emergency surgery is the main treatment for Acute Aortic Dissection. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Aortic Dissection
What is being tested?
xenon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Feb 2016to Sep 2018
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients doing selective operation of Bentall and Sun's or partial aortic arch replacement
  • Patients doing selective operation of the full chest and abdominal aorta replacement

Who cannot join

  • Emergency patient
  • Patients with severe mental and neurological dysfunction
  • Patients with severe hearing and visual impairment
  • Illiteracy or patients can't cooperate with doing the cognitive function score
  • Patients with severe cardiac insufficiency
  • critically ill or dying patients
  • Patients refuse to sign the informed consent

About this study

With more and more people developing hypertension and atherosclerosis, the morbidity rate of Acute Aortic Dissection（AAD） has been increasing. Emergency surgery is the main treatment for Acute Aortic Dissection. However the secondary injury caused by reperfusion of spinal cord could lead to Catastrophic complications,such as paraplegia, hemiplegia or even death. So spinal protection is always the hot topic in clinical research.

Xenon is an ideal anesthetic gases with the following features,fast onset of action, stable hemodynamics, clean and non-toxic.The animal researches have showed the protective effects of xenon to alleviate the ischemia-reperfusion injury of the nervous system.Those clues suggest that Xenon may have the potential protection of spinal cord in patients undergoing aortic dissection repair.In order to clarify this hypothesis, the investigators designed this randomized, controlled clinic trial to evaluate the protection of Xenon against spinal cord ischemia-reperfusion injury and the potential mechanisms

Being tested
xenon
Keywords
Aortic dissection, Cerebral and Spinal Protection, Post-conditioning
Medical subject headings
Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • xenonDrug

Study groups in NCT02774096
Study groupRoleWhat they receive
Control group（Ascending aorta）No interventionundergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
Xenon Post-conditioningExperimentalundergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
Receives: Drug: xenon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mini mental state examination

    Measured: 18h before the surgery

  2. NIHSS's score

    Measured: the 1st day after the surgery

  3. ASIA impairment scale（ASIA's score ）

    Measured: 18h before the surgery

  4. males

    Measured: 18h before the surgery

  5. age

    Measured: 18h before the surgery

  6. height

    Measured: 18h before the surgery

  7. weight

    Measured: 18h before the surgery

  8. History of Smoking

    Measured: 18h before the surgery

  9. History of Hypertension

    Measured: 18h before the surgery

  10. History of Diabetes Mellitus

    Measured: 18h before the surgery

  11. New York Heart Association Heart function score

    Measured: 18h before the surgery

  12. duration of cardiopulmonary bypass (CPB)

    Measured: 1h after the surgery

  13. duration of Aortic cross-clamping

    Measured: 1h after the surgery

  14. duration of low flow in CPB

    Measured: 1h after the surgery

  15. duration of stopping the circulation

    Measured: 1h after the surgery

  16. the lowest nasopharyngeal temperature

    Measured: 1h after the surgery

  17. the lowest rectal temperature

    Measured: 1h after the surgery

  18. duration of surgery

    Measured: 1h after the surgery

  19. duration of recovering of consciousness from the end of the surgery

    Measured: 3 days after the surgery

  20. duration of extubation from the end of the surgery

    Measured: 3 days after the surgery

  21. duration in the ICU

    Measured: 15 days after the surgery

  22. days in hospital

    Measured: 15 days after leaving hospital

  23. pulmonary infection

    Measured: 15 days after the surgery

  24. plasma S100β

    Measured: immediately after anesthesia induction

  25. plasma neuron specific enolase,

    Measured: immediately after anesthesia induction

  26. plasma myelin basic protein(MBP)

    Measured: immediately after anesthesia induction

  27. plasma glial fibrillary acidic protein (GFAP)

    Measured: immediately after anesthesia induction

  28. Cerebrospinal fluid(CSF) S100β

    Measured: immediately after anesthesia induction

  29. CSF neuron specific enolase(NSE),

    Measured: immediately after anesthesia induction

  30. CSF MBP

    Measured: immediately after anesthesia induction

  31. CSF GFAP

    Measured: immediately after anesthesia induction

  32. CSF Tumor Necrosis Factor-α(TNF-α)

    Measured: immediately after anesthesia induction

  33. CSF interleukin-10 (IL-10)

    Measured: immediately after anesthesia induction

  34. CSF IL-6

    Measured: immediately after anesthesia induction

  35. CSF IL-2

    Measured: immediately after anesthesia induction

  36. somatosensory evoked potential(SEP)

    Measured: immediately after anesthesia induction

  37. MEP

    Measured: immediately after anesthesia induction

  38. Mini mental state ex amination

    Measured: the 7th day after the surgery

  39. NIHSS's score

    Measured: the 2nd day after the surgery

  40. NIHSS's score

    Measured: the 3rd day after the surgery

  41. ASIA's score

    Measured: the 1st day after the surgery

  42. ASIA's score

    Measured: the 2nd day after the surgery

  43. ASIA's score

    Measured: the 3rd day after the surgery

  44. plasma S100β

    Measured: immediately the end of surgery

  45. plasma S100β

    Measured: the 1st day after the surgery

  46. plasma S100β

    Measured: the 3rd day after the surgery

  47. plasma S100β

    Measured: the 7th day after the surgery

  48. plasma neuron specific enolase,

    Measured: immediately the end of surgery

  49. plasma neuron specific enolase,

    Measured: the 1st day after the surgery

  50. plasma neuron specific enolase,

    Measured: the 3rd day after the surgery

  51. plasma neuron specific enolase,

    Measured: the 7th day after the surgery

  52. plasma MBP

    Measured: immediately the end of surgery

  53. plasma MBP

    Measured: the 1st day after the surgery

  54. plasma MBP

    Measured: the 3rd day after the surgery

  55. plasma MBP

    Measured: the 7th day after the surgery

  56. plasma GFAP

    Measured: immediately the end of surgery

  57. plasma GFAP

    Measured: the 1st day after the surgery

  58. plasma GFAP

    Measured: the 3rd day after the surgery

  59. plasma GFAP

    Measured: the 7th day after the surgery

  60. CSF S100β

    Measured: immediately the end of surgery

  61. CSF S100β

    Measured: the 1st day after the surgery

  62. CSF S100β

    Measured: the 2nd day after the surgery

  63. CSF S100β

    Measured: the 3rd day after the surgery

  64. CSF neuron specific enolase,

    Measured: immediately the end of surgery

  65. CSF neuron specific enolase,

    Measured: the 1st day after the surgery

  66. CSF neuron specific enolase,

    Measured: the 2nd day after the surgery

  67. CSF neuron specific enolase,

    Measured: the 3rd day after the surgery

  68. CSF MBP

    Measured: immediately the end of surgery

  69. CSF MBP

    Measured: the 1st day after the surgery

  70. CSF MBP

    Measured: the 2nd day after the surgery

  71. CSF MBP

    Measured: the 3rd day after the surgery

  72. CSF GFAP

    Measured: immediately the end of surgery

  73. CSF GFAP

    Measured: the 1st day after the surgery

  74. CSF GFAP

    Measured: the 2nd day after the surgery

  75. CSF GFAP

    Measured: the 3rd day after the surgery

  76. CSF TNF-α

    Measured: immediately the end of surgery

  77. CSF TNF-α

    Measured: the 1st day after the surgery

  78. CSF TNF-α

    Measured: the 2nd day after the surgery

  79. CSF TNF-α

    Measured: the 3rd day after the surgery

  80. CSF IL-10

    Measured: immediately the end of surgery

  81. CSF IL-10

    Measured: the 1st day after surgery

  82. CSF IL-10

    Measured: the 2nd day after surgery

  83. CSF IL-10

    Measured: the 3rd day after surgery

  84. CSF IL-6

    Measured: immediately the end of surgery

  85. CSF IL-6

    Measured: the 1st day after surgery

  86. CSF IL-6

    Measured: the 2nd day after surgery

  87. CSF IL-6

    Measured: the 3rd day after surgery

  88. CSF IL-2

    Measured: immediately the end of surgery

  89. CSF IL-2

    Measured: the 1st day after surgery

  90. CSF IL-2

    Measured: the 2nd day after surgery

  91. CSF IL-2

    Measured: the 3rd day after surgery

  92. SEP

    Measured: immediately after blocking the aorta

  93. SEP

    Measured: immediately after opening the aorta

  94. SEP

    Measured: immediately the end of the surgery

  95. SEP

    Measured: the 4th hour after back to ICU

  96. MEP

    Measured: immediately after blocking the aorta

  97. MEP

    Measured: immediately after opening the aorta

  98. MEP

    Measured: immediately the end of the surgery

  99. MEP

    Measured: the 4th hour after back to ICU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionJul 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02774096
Sponsor's protocol ID
WCheng 2014-8-24
Status last verified
May 2016
First submitted
25 Apr 2016
Last updated
17 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing xenon in people with Aortic Dissection, run by Beijing Anzhen Hospital.

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 2 inclusion and 7 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mini mental state examination (time frame: 18h before the surgery). The study lists 99 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02774096.

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 17 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in