VitamIn and oXygen Interventions and Cardiovascular Events

NCT ID: NCT03494387

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2020-03-24

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: DRUG

80% versus 30% inspiratory oxygen concentration

Antioxidants

Intervention Type: DRUG

Antioxidants versus placebo

2

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: DRUG

80% versus 30% inspiratory oxygen concentration

Antioxidants

Intervention Type: DRUG

Antioxidants versus placebo

Interventions

Oxygen

80% versus 30% inspiratory oxygen concentration

Intervention Type: DRUG

Antioxidants

Antioxidants versus placebo

Intervention Type: DRUG

Other Intervention Names

Ascorbic acid; N-acetylcysteine

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: lead

Responsible Party

Cecilie Petersen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abdominalcentret, Rigshospitalet

Copenhagen, , Denmark

HovedOrtoCentret, Rigshospitalet

Copenhagen, , Denmark

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Copenhagen, , Denmark

Herlev Hospital

Herlev, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 41055553 (View on PubMed)

Other Identifiers

VIXIE2018

Identifier Type: -

Identifier Source: org_study_id