Postoperative Cardiac ComplicationPhase 4VIXIENCT03494387
VitamIn and oXygen Interventions and Cardiovascular Events
A Phase 4 study testing Oxygen and Antioxidants in people with Postoperative Cardiac Complication, run by University Hospital Bispebjerg and Frederiksberg at 4 sites in Denmark.
Trial summary
This study examines the risks and benefits of antioxidants and normal versus high inspiratory oxygen fraction during anaesthesia. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Postoperative Cardiac Complication
- What is being tested?
- Oxygen and Antioxidants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 4 sitesDenmark
- Study dates
- 6 Apr 2018to 24 Mar 2020
- Phase
- Phase 4
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of the listed criteria (1.-4.) must be met.
- Age 45 years or above
- Elective or acute surgery in general anaesthesia
- Scheduled for abdominal, orthopaedic, or vascular surgery with expected surgery duration of one hour or more.
- Fulfil any 1 of the following 5 criteria:
- - History of coronary artery disease including angina
Show all 10Show fewer
- - History of stroke
- - Undergoing vascular surgery
- - History of peripheral arterial disease
- - 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
Who cannot join
- Surgery within 30 days prior to operation
- Arterial oxygen saturation below 90% without oxygen supplementation
- Inability to give informed consent
- Drug allergy towards any of the drugs involved in the trial
- Previous treatment with bleomycin
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Abdominalcentret, Rigshospitalet
Copenhagen, 2100
HovedOrtoCentret, Rigshospitalet
Copenhagen, 2100
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen
Herlev Hospital
Herlev
About this study
Official title: Hyperoxia and Antioxidants During Major Non-cardiac Surgery and Risk of Cardiovascular Complications, a Blinded 2x2 Factorial Randomised Clinical Trial
This study examines the risks and benefits of antioxidants and normal versus high inspiratory oxygen fraction during anaesthesia.
Read the 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.
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.
- Conditions
- Postoperative Cardiac Complication
- Being tested
- Oxygen, Antioxidants
- Keywords
- Antioxidant, Hyperoxia, Troponin, MINS, Ascorbic acid, N-acetylcysteine
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
80% versus 30% inspiratory oxygen concentration
AntioxidantsDrug
Also called Ascorbic acid, N-acetylcysteine
Antioxidants versus placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Oxygen; Drug: Antioxidants |
| 2 | Experimental | Not described Receives: Drug: Oxygen; Drug: Antioxidants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury after non-cardiac surgery (MINS)
Troponin measurement the first 3 postoperative days. Assessed by area under the curve.
Measured: 30 days
Secondary outcomes (3)
Mortality
Assessed as time to event analysis
Measured: During the study period until completion of last visit of last patient
Non-fatal myocardial infarction
Assessed as time to event analysis
Measured: During the study period until completion of last visit of last patient
Non-fatal Serious Adverse Event
Assessed as time to event analysis
Measured: During the study period until completion of last visit of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start6 Apr 2018
- Primary completion1 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cardiac ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilie Petersen, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494387
- Sponsor's protocol ID
- VIXIE2018
- Acronym
- VIXIE
- Status last verified
- Apr 2021
- First submitted
- 21 Mar 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loft FC, Holse C, Aasvang EK, Vester-Andersen M, Rasmussen LS, Jorgensen LN, Meyhoff CS. Effects of Hyperoxia and Antioxidants on Mortality, Hospital Admissions, and Myocardial Infarction After Noncardiac Surgery: 1-Year Follow-Up of a Randomized Controlled Trial. Acta Anaesthesiol Scand. 2025 Nov;69(10):e70118. doi: 10.1111/aas.70118.
PubMed 41055553
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperoxia and Antioxidants During Major Non-cardiac Surgery and Risk of Cardiovascular Complications, a Blinded 2x2 Factorial Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03494387
- Acronym / sponsor ID
- VIXIE / VIXIE2018
- Conditions
- Postoperative Cardiac Complication
- Keywords
- Antioxidant, Hyperoxia, Troponin, MINS, Ascorbic acid, N-acetylcysteine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the risks and benefits of antioxidants and normal versus high inspiratory oxygen fraction during anaesthesia.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oxygen, Drug: Antioxidants |
| 2 | Experimental | Drug: Oxygen, Drug: Antioxidants |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All of the listed criteria (1.-4.) must be met.
- Age 45 years or above
- Elective or acute surgery in general anaesthesia
- Scheduled for abdominal, orthopaedic, or vascular surgery with expected surgery duration of one hour or more.
- Fulfil any 1 of the following 5 criteria:
Key exclusion criteria (6 listed)
- Surgery within 30 days prior to operation
- Arterial oxygen saturation below 90% without oxygen supplementation
- Inability to give informed consent
- Drug allergy towards any of the drugs involved in the trial
- Previous treatment with bleomycin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen80% versus 30% inspiratory oxygen concentration | Drug | 1, 2 |
| AntioxidantsAlso: Ascorbic acid, N-acetylcysteineAntioxidants versus placebo | Drug | 1, 2 |
Primary outcome
Myocardial injury after non-cardiac surgery (MINS)
Time frame: 30 days
Troponin measurement the first 3 postoperative days. Assessed by area under the curve.
3 secondary outcomes
Mortality
Time frame: During the study period until completion of last visit of last patient
Non-fatal myocardial infarction
Time frame: During the study period until completion of last visit of last patient
Non-fatal Serious Adverse Event
Time frame: During the study period until completion of last visit of last patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 41055553Loft FC, Holse C, Aasvang EK, Vester-Andersen M, Rasmussen LS, Jorgensen LN, Meyhoff CS. Effects of Hyperoxia and Antioxidants on Mortality, Hospital Admissions, and Myocardial Infarction After Noncardiac Surgery: 1-Year Follow-Up of a Randomized Controlled Trial. Acta Anaesthesiol Scand. 2025 Nov;69(10):e70118. doi: 10.1111/aas.70118.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxygen and Antioxidants in people with Postoperative Cardiac Complication, run by University Hospital Bispebjerg and Frederiksberg at 4 sites in Denmark.
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 10 inclusion and 6 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: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Myocardial injury after non-cardiac surgery (MINS) (time frame: 30 days). 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 NCT03494387, which also lists 1 linked publication.
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 30 Apr 2021.