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Trial record 8 of 667 for:    CARBON DIOXIDE AND arterial

Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms. (CANON)

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ClinicalTrials.gov Identifier: NCT03074604
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Krzysztof Szwed, Collegium Medicum w Bydgoszczy

Brief Summary:
The objective of this study is to investigate the value of employing the aortic no-touch off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary revascularization.

Condition or disease Intervention/treatment Phase
Neurological Injury Stroke Postoperative Cognitive Dysfunction Postoperative Delirium Coronary Artery Disease Coronary Artery Bypass Surgery Off-Pump Coronary Artery Bypass Procedure: aortic no-touch OPCABG Procedure: OPCABG with partial clamp applying carbon dioxide Procedure: OPCABG with partial clamp Not Applicable

Detailed Description:

Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offset survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue, is off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques.

In this randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment and one control arms. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with a partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG. The primary endpoint will be the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The CANON trial is designed as a randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms and a primary endpoint being the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms.
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aortic no-touch OPCABG
aortic no-touch OPCABG
Procedure: aortic no-touch OPCABG
(Study arm 1) In this intervention only the internal mammary artery grafts will be used (i.e. left internal mammary artery graft, right internal mammary artery graft, or a Y-graft that uses right internal mammary artery graft anastomosed onto left internal mammary artery graft to allow for a wide territory of myocardial revascularization). However, in the rare event that the aforementioned approach is insufficient to reach all target vessels, a reversed (great) saphenous vein graft may be used to extend the left internal mammary artery graft or the right internal mammary artery graft.

Experimental: OPCABG with partial clamp applying carbon dioxide
OPCABG with partial clamp applying carbon dioxide
Procedure: OPCABG with partial clamp applying carbon dioxide
(Study arm 2) In this intervention chest cavity will be insufflated with carbon dioxide at a flow above 5 l/min during the entire surgical procedure.

Active Comparator: OPCABG with partial clamp
OPCABG with partial clamp
Procedure: OPCABG with partial clamp
(Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp.




Primary Outcome Measures :
  1. New lesions on control brain magnetic resonance imaging. [ Time Frame: 3 days after surgery ]
    Appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.


Secondary Outcome Measures :
  1. New focal neurological deficits. [ Time Frame: 7 days after surgery ]
    Prevalence of new focal neurological deficits in the first 7 days after surgery.

  2. Occurence of postoperative cognitive dysfunction [ Time Frame: 1 week or 3 months after surgery ]
    Occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery

  3. Incidence of delirium [ Time Frame: 7 days after surgery ]
    Incidence of delirium in the first 7 days after surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective and/or urgent coronary artery bypass

Exclusion Criteria:

  • emergent and salvage setting
  • score below age- and education-adjusted cut-off scores in mini mental state examination
  • score above 8 on the subscales of hospital anxiety and depression scale
  • neurologic deficit of any etiology
  • previous psychiatric illness
  • use of tranquilizers or antipsychotics
  • alcohol or drug abuse
  • history of cardiac surgery
  • left ventricular ejection fraction less than 30%
  • extracranial carotid artery stenosis of more than 70%
  • body mass index of more than 35 kg/m2
  • any contraindication for magnetic resonance imaging (e.g., magnetic resonance imaging - incompatible implantable device and claustrophobia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074604


Contacts
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Contact: Krzysztof Szwed, M.D. Ph.D. 698622325 ext +48 a.k.szwed@gmail.com
Contact: Mariusz Kowalewski, M.D. Ph.D. 502269240 ext +48 kowalewskimariusz@gazeta.pl

Locations
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Poland
Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital Recruiting
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-001
Contact: Mariusz Kowalewski, M.D. Ph.D.    502269240 ext +48    kowalewskimariusz@gazeta.pl   
Sponsors and Collaborators
Collegium Medicum w Bydgoszczy
Investigators
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Principal Investigator: Krzysztof Szwed, M.D. Ph.D. Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
Study Chair: Alina Borkowska, Professor Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Krzysztof Szwed, Dr., Collegium Medicum w Bydgoszczy
ClinicalTrials.gov Identifier: NCT03074604     History of Changes
Other Study ID Numbers: KB 60/2017
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Krzysztof Szwed, Collegium Medicum w Bydgoszczy:
Coronary Artery Disease
Coronary Artery Bypass Grafting
Coronary Artery Bypass Surgery
Beating Heart Coronary Artery Bypass
Off-Pump Coronary Artery Bypass
Brain Injuries
Neurological Injury
Stroke
Postoperative Cognitive Dysfunction
Postoperative Delirium
Bypass surgery
Additional relevant MeSH terms:
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Coronary Artery Disease
Arterial Occlusive Diseases
Delirium
Trauma, Nervous System
Myocardial Ischemia
Coronary Disease
Cognitive Dysfunction
Wounds and Injuries
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cognition Disorders