VitamIn and oXygen Interventions and Cardiovascular Events

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

Sponsors

Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

Source 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.

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.

Overall Status Completed
Start Date April 6, 2018
Completion Date March 24, 2020
Primary Completion Date March 1, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Myocardial injury after non-cardiac surgery (MINS) 30 days
Secondary Outcome
Measure Time Frame
Mortality During the study period until completion of last visit of last patient
Non-fatal myocardial infarction During the study period until completion of last visit of last patient
Non-fatal Serious Adverse Event During the study period until completion of last visit of last patient
Enrollment 600
Condition
Intervention

Intervention Type: Drug

Intervention Name: Oxygen

Description: 80% versus 30% inspiratory oxygen concentration

Intervention Type: Drug

Intervention Name: Antioxidants

Description: Antioxidants versus placebo

Eligibility

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

Gender: All

Minimum Age: 45 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Abdominalcentret, Rigshospitalet | Copenhagen, 2100, Denmark
HovedOrtoCentret, Rigshospitalet | Copenhagen, 2100, Denmark
Bispebjerg and Frederiksberg Hospital, University of Copenhagen | Copenhagen, Denmark
Herlev Hospital | Herlev, Denmark
Location Countries

Denmark

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University Hospital Bispebjerg and Frederiksberg

Investigator Full Name: Cecilie Petersen

Investigator Title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Label: 2

Type: Experimental

Acronym VIXIE
Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov