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VitamIn and oXygen Interventions and Cardiovascular Events (VIXIE)

Primary Purpose

Postoperative Cardiac Complication

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Oxygen

Antioxidants

About this trial

This is an interventional prevention trial for Postoperative Cardiac Complication focused on measuring Antioxidant, Hyperoxia, Troponin, MINS, Ascorbic acid, N-acetylcysteine

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Abdominalcentret, Rigshospitalet
HovedOrtoCentret, Rigshospitalet
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Myocardial injury after non-cardiac surgery (MINS)

Troponin measurement the first 3 postoperative days. Assessed by area under the curve.

Secondary Outcome Measures

Mortality

Assessed as time to event analysis

Non-fatal myocardial infarction

Assessed as time to event analysis

Non-fatal Serious Adverse Event

Assessed as time to event analysis

Full Information

NCT ID

NCT03494387

First Posted

March 21, 2018

Last Updated

April 27, 2021

Sponsor

University Hospital Bispebjerg and Frederiksberg

1. Study Identification

Unique Protocol Identification Number

NCT03494387

Brief Title

VitamIn and oXygen Interventions and Cardiovascular Events

Acronym

VIXIE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

April 6, 2018 (Actual)

Primary Completion Date

March 1, 2020 (Actual)

Study Completion Date

March 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Bispebjerg and Frederiksberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Cardiac Complication

Keywords

Antioxidant, Hyperoxia, Troponin, MINS, Ascorbic acid, N-acetylcysteine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Oxygen

Intervention Description

80% versus 30% inspiratory oxygen concentration

Intervention Type

Drug

Intervention Name(s)

Antioxidants

Other Intervention Name(s)

Ascorbic acid, N-acetylcysteine

Intervention Description

Antioxidants versus placebo

Primary Outcome Measure Information:

Title

Myocardial injury after non-cardiac surgery (MINS)

Description

Troponin measurement the first 3 postoperative days. Assessed by area under the curve.

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Mortality

Description

Assessed as time to event analysis

Time Frame

During the study period until completion of last visit of last patient

Title

Non-fatal myocardial infarction

Description

Assessed as time to event analysis

Time Frame

During the study period until completion of last visit of last patient

Title

Non-fatal Serious Adverse Event

Description

Assessed as time to event analysis

Time Frame

During the study period until completion of last visit of last patient

Other Pre-specified Outcome Measures:

Title

Surgical site infection

Description

Infection in surgical area as defined by the Center for Disease Control

Time Frame

Assessed at postoperative day 30

Title

Pneumonia

Description

Pneumonia as defined by the Center for Disease Control

Time Frame

Assessed at postoperative day 30

Title

Sepsis

Description

Sepsis as defined by the joint task force by the European Society of Intensive Care Medicine and the Society of Critical Care Medicine

Time Frame

Assessed at postoperative day 30

Title

Acute respiratory failure

Description

Acute respiratory failure defined as the need for controlled ventilation or oxygen saturation of 900% or less despite of oxygen therapy

Time Frame

Assessed at postoperative day 30

Title

Acute kidney injury

Description

Acute kidney injury as defined Kidney Disease Improving Global Outcomes guidelines

Time Frame

Assessed at postoperative day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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: - History of coronary artery disease including angina - History of stroke - Undergoing vascular surgery - History of peripheral arterial disease - 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

Facility Information:

Facility Name

Abdominalcentret, Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

HovedOrtoCentret, Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

City

Copenhagen

Country

Denmark

Facility Name

Herlev Hospital

City

Herlev

Country

Denmark

12. IPD Sharing Statement

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VitamIn and oXygen Interventions and Cardiovascular Events

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