VitamIn and oXygen Interventions and Cardiovascular Events | NCT03494387

Studies
VitamIn and oXygen Interventions and Cardiovascular Events

NCT03494387

Sponsor

University Hospital Bispebjerg and Frederiksberg

Status

Completed

Last Update Posted

Apr 30, 2021Actual

Enrollment

600Actual

Phase

Phase 4

Conditions

Postoperative Cardiac Complication

Interventions

Oxygen
Antioxidants

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2018Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Mar 24, 2020Actual

First Submitted Date

Mar 21, 2018

First Submission Date that Met QC Criteria

Apr 10, 2018

First Posted Date

Apr 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2021

Last Update Posted Date

Apr 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: Oxygen Drug: Antioxidants
2	Experimental		Drug: Oxygen Drug: Antioxidants

Name	Type	Description	Arm Group Labels	Other Names
Oxygen	Drug	80% versus 30% inspiratory oxygen concentration	1 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Assessed as time to event analysis	During the study period until completion of last visit of last patient
Non-fatal myocardial infarction	Assessed as time to event analysis

Other Outcomes

Measure	Description	Time Frame
Surgical site infection	Infection in surgical area as defined by the Center for Disease Control	Assessed at postoperative day 30
Pneumonia	Pneumonia as defined by the Center for Disease Control

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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:
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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Abdominalcentret, Rigshospitalet		Copenhagen		2100	Denmark
HovedOrtoCentret, Rigshospitalet

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41055553	Derived	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.

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010100	Oxygen
D000975	Antioxidants
D001205	Ascorbic Acid
D000111	Acetylcysteine

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases
D001685