VitamIn and oXygen Interventions and Cardiovascular Events

Phase 4

Completed

• Conditions: Postoperative Cardiac Complication
• Interventions: Drug: Oxygen; Drug: Antioxidants

• Registration Number: NCT03494387
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-03-21
• Study Start: 2018-04-06
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-11
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-24
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Antioxidants	-
2	Oxygen	-
2	Antioxidants	-
1	Oxygen	-

Primary Outcome Measures

Name	Time	Method
Myocardial injury after non-cardiac surgery (MINS)	30 days	Troponin measurement the first 3 postoperative days. Assessed by area under the curve.

Secondary Outcome Measures

Name	Time	Method
Non-fatal myocardial infarction	During the study period until completion of last visit of last patient	Assessed as time to event analysis
Non-fatal Serious Adverse Event	During the study period until completion of last visit of last patient	Assessed as time to event analysis
Mortality	During the study period until completion of last visit of last patient	Assessed as time to event analysis

Trial Locations

Locations (4)

HovedOrtoCentret, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Bispebjerg and Frederiksberg Hospital, University of Copenhagen; 🇩🇰 Copenhagen, Denmark

Abdominalcentret, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark