VitamIn and oXygen Interventions and Cardiovascular Events

Postoperative Cardiac Complication Clinical Trial

— VIXIE  

Official title:

Hyperoxia and Antioxidants During Major Non-cardiac Surgery and Risk of Cardiovascular Complications, a Blinded 2x2 Factorial Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494387
• Other study ID #: VIXIE2018
• Status: Completed
• Phase: Phase 4
• Start date: April 6, 2018
• Est. completion date: March 24, 2020

Study information

• Verified date: April 2021
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 24, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperoxia
• Postoperative Cardiac Complication

Intervention

Drug:
• Oxygen
80% versus 30% inspiratory oxygen concentration
• Antioxidants
Antioxidants versus placebo

Locations

Country	Name	City	State
Denmark	Abdominalcentret, Rigshospitalet	Copenhagen
Denmark	Bispebjerg and Frederiksberg Hospital, University of Copenhagen	Copenhagen
Denmark	HovedOrtoCentret, Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical site infection	Infection in surgical area as defined by the Center for Disease Control	Assessed at postoperative day 30
Other	Pneumonia	Pneumonia as defined by the Center for Disease Control	Assessed at postoperative day 30
Other	Sepsis	Sepsis as defined by the joint task force by the European Society of Intensive Care Medicine and the Society of Critical Care Medicine	Assessed at postoperative day 30
Other	Acute respiratory failure	Acute respiratory failure defined as the need for controlled ventilation or oxygen saturation of 900% or less despite of oxygen therapy	Assessed at postoperative day 30
Other	Acute kidney injury	Acute kidney injury as defined Kidney Disease Improving Global Outcomes guidelines	Assessed at postoperative day 30
Primary	Myocardial injury after non-cardiac surgery (MINS)	Troponin measurement the first 3 postoperative days. Assessed by area under the curve.	30 days
Secondary	Mortality	Assessed as time to event analysis	During the study period until completion of last visit of last patient
Secondary	Non-fatal myocardial infarction	Assessed as time to event analysis	During the study period until completion of last visit of last patient
Secondary	Non-fatal Serious Adverse Event	Assessed as time to event analysis	During the study period until completion of last visit of last patient