NCT03494387

Brief Summary

This study examines the risks and benefits of antioxidants and normal versus high inspiratory oxygen fraction during anaesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

April 6, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2020

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

March 21, 2018

Last Update Submit

April 27, 2021

Conditions

Postoperative Cardiac Complication

Keywords

AntioxidantHyperoxiaTroponinMINSAscorbic acidN-acetylcysteine

Outcome Measures

Primary Outcomes (1)

  • Myocardial injury after non-cardiac surgery (MINS)

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

    30 days

Secondary Outcomes (3)

  • 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

Other Outcomes (5)

  • Surgical site infection

    Assessed at postoperative day 30

  • Pneumonia

    Assessed at postoperative day 30

  • Sepsis

    Assessed at postoperative day 30

  • +2 more other outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: OxygenDrug: Antioxidants

2

EXPERIMENTAL
Drug: OxygenDrug: Antioxidants

Interventions

OxygenDRUG

80% versus 30% inspiratory oxygen concentration

12
AntioxidantsDRUG

Antioxidants versus placebo

Also known as: Ascorbic acid, N-acetylcysteine
12

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Abdominalcentret, Rigshospitalet

Copenhagen, 2100, Denmark

Location

HovedOrtoCentret, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Copenhagen, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 41055553DERIVED

MeSH Terms

Conditions

Hyperoxia

Interventions

OxygenAntioxidantsAscorbic AcidAcetylcysteine

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesBiological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of ChemicalsSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesCysteineAmino Acids, SulfurSulfur CompoundsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 21, 2018

First Posted

April 11, 2018

Study Start

April 6, 2018

Primary Completion

March 1, 2020

Study Completion

March 24, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations

DK(4)