A Phase 4 interventional study of Oxygen and Antioxidants in Postoperative Cardiac Complication, sponsored by University Hospital Bispebjerg and Frederiksberg. Completed at 4 sites in Denmark. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University Hospital Bispebjerg and Frederiksberg · Phase 4, Interventional, and Prevention
This study examines the risks and benefits of antioxidants and normal versus high inspiratory oxygen fraction during anaesthesia.
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.
The study is a long-term follow-up study of the risk of mortality, MI and readmissions performed at 1 year after inclusion of the last patient. Two other follow-up studies are planned: One investigation of ischaemic troponin elevations defined as peak troponin levels above the internationally defined thresholds without extracardiac causes; another investigating 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.
115 studies on the registry are indexed under Hyperoxia; 13 are open to participants now.
This study's enrollment of 600 is above the median of 48 across 82 interventional studies indexed under Hyperoxia.
Browse Hyperoxia studies →University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 69 studies on the registry; 18 are open to participants now.
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All of the listed criteria (1.-4.) must be met.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Oxygen · Drug: Antioxidants
Drug: Oxygen · Drug: Antioxidants
80% versus 30% inspiratory oxygen concentration
Antioxidants versus placebo
Also known as: Ascorbic acid, N-acetylcysteine
Myocardial injury after non-cardiac surgery (MINS)
Troponin measurement the first 3 postoperative days. Assessed by area under the curve.
Time frame: 30 days
Mortality
Assessed as time to event analysis
Time frame: During the study period until completion of last visit of last patient
Non-fatal myocardial infarction
Assessed as time to event analysis
Time frame: During the study period until completion of last visit of last patient
Non-fatal Serious Adverse Event
Assessed as time to event analysis
Time frame: During the study period until completion of last visit of last patient
Surgical site infection
Infection in surgical area as defined by the Center for Disease Control
Time frame: Assessed at postoperative day 30
Pneumonia
Pneumonia as defined by the Center for Disease Control
Time frame: Assessed at postoperative day 30
Sepsis
Sepsis as defined by the joint task force by the European Society of Intensive Care Medicine and the Society of Critical Care Medicine
Time frame: Assessed at postoperative day 30
Acute respiratory failure
Acute respiratory failure defined as the need for controlled ventilation or oxygen saturation of 900% or less despite of oxygen therapy
Time frame: Assessed at postoperative day 30
Acute kidney injury
Acute kidney injury as defined Kidney Disease Improving Global Outcomes guidelines
Time frame: Assessed at postoperative day 30
Ran from Apr 2018 to primary completion in Mar 2020, 22 months.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Oxygen · Antioxidants
University Hospital Bispebjerg and Frederiksberg