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VitamIn and oXygen Interventions and Cardiovascular Events (VIXIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494387
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Cecilie Petersen, University Hospital Bispebjerg and Frederiksberg

Brief Summary:
This study examines the risks and benefits of antioxidants and normal versus high inspiratory oxygen fraction during anaesthesia.

Condition or disease Intervention/treatment Phase
Postoperative Cardiac Complication Drug: Oxygen Drug: Antioxidants Phase 4

Detailed Description:

Adult patients with risk factors for developing postoperative cardiac complications will be enrolled in the study. The patients will be randomised to receiving antioxidants or placebo perioperatively and 30% or 80% inspiratory oxygen concentration during anaesthesia and 2 hours postoperatively. The primary outcome is MINS (myocardial injury after non-cardiac surgery). The antioxidants are ascorbic acid (vitamin C) 3 grams intravenously preoperatively and N-acetylcysteine 100 milligrams/kilogram body weight intravenous infusion for 4 hours, starting at the same time as anaesthesia.

We plan a long-term follow-up study of the risk of mortality, MI and readmissions performed at 1 year after inclusion of the last patient. We plan two other follow-up study: One in which we investigate ischaemic troponin elevations defined as peak troponin levels above the internationally defined thresholds without extracardiac causes; another in which we in detail analyse the intervention effects in the subgroup of patients undergoing vascular surgery with specific emphasis on episodes of intraoperative hypotension within the following thresholds: MAP below 70 mmHg, 65 mmHg, 60 mmHg and 55 mmHg.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hyperoxia and Antioxidants During Major Non-cardiac Surgery and Risk of Cardiovascular Complications, a Blinded 2x2 Factorial Randomised Clinical Trial
Actual Study Start Date : April 6, 2018
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: Oxygen
80% versus 30% inspiratory oxygen concentration

Drug: Antioxidants
Antioxidants versus placebo
Other Names:
  • Ascorbic acid
  • N-acetylcysteine

Experimental: 2 Drug: Oxygen
80% versus 30% inspiratory oxygen concentration

Drug: Antioxidants
Antioxidants versus placebo
Other Names:
  • Ascorbic acid
  • N-acetylcysteine




Primary Outcome Measures :
  1. Myocardial injury after non-cardiac surgery (MINS) [ Time Frame: 30 days ]
    Troponin measurement the first 3 postoperative days. Assessed by area under the curve.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: During the study period until completion of last visit of last patient ]
    Assessed as time to event analysis

  2. Non-fatal myocardial infarction [ Time Frame: During the study period until completion of last visit of last patient ]
    Assessed as time to event analysis

  3. Non-fatal Serious Adverse Event [ Time Frame: During the study period until completion of last visit of last patient ]
    Assessed as time to event analysis


Other Outcome Measures:
  1. Surgical site infection [ Time Frame: Assessed at postoperative day 30 ]
    Infection in surgical area as defined by the Center for Disease Control

  2. Pneumonia [ Time Frame: Assessed at postoperative day 30 ]
    Pneumonia as defined by the Center for Disease Control

  3. Sepsis [ Time Frame: Assessed at postoperative day 30 ]
    Sepsis as defined by the joint task force by the European Society of Intensive Care Medicine and the Society of Critical Care Medicine

  4. Acute respiratory failure [ Time Frame: Assessed at postoperative day 30 ]
    Acute respiratory failure defined as the need for controlled ventilation or oxygen saturation of 900% or less despite of oxygen therapy

  5. Acute kidney injury [ Time Frame: Assessed at postoperative day 30 ]
    Acute kidney injury as defined Kidney Disease Improving Global Outcomes guidelines



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

All of the listed criteria (1.-4.) must be met.

  1. Age 45 years or above
  2. Elective or acute surgery in general anaesthesia
  3. Scheduled for abdominal, orthopaedic, or vascular surgery with expected surgery duration of one hour or more.
  4. Fulfil any 1 of the following 5 criteria:

    1. - History of coronary artery disease including angina
    2. - History of stroke
    3. - Undergoing vascular surgery
    4. - History of peripheral arterial disease
    5. - Any 2 of the following 8 criteria: i. Acute surgery ii. Current or previous daily smoking iii. History of hypertension iv. Diabetes mellitus requiring medical treatment v. History of transient cerebral ischemia vi. Plasma creatinine >175 µM vii. Age 70 years or above viii. History of congestive heart failure

Exclusion criteria:

  1. Surgery within 30 days prior to operation
  2. Arterial oxygen saturation below 90% without oxygen supplementation
  3. Inability to give informed consent
  4. Drug allergy towards any of the drugs involved in the trial
  5. Previous treatment with bleomycin
  6. Pregnancy

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): NCT03494387


Locations
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Denmark
Abdominalcentret, Rigshospitalet
Copenhagen, Denmark, 2100
HovedOrtoCentret, Rigshospitalet
Copenhagen, Denmark, 2100
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
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Responsible Party: Cecilie Petersen, MD, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT03494387    
Other Study ID Numbers: VIXIE2018
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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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 Cecilie Petersen, University Hospital Bispebjerg and Frederiksberg:
Antioxidant
Hyperoxia
Troponin
MINS
Ascorbic acid
N-acetylcysteine
Additional relevant MeSH terms:
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Hyperoxia
Signs and Symptoms, Respiratory
Ascorbic Acid
Acetylcysteine
Antioxidants
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances