Hyperoxia and antioxidants during major non-cardiac surgery and risk of cardiovascular events: Protocol for a 2 × 2 factorial randomised clinical trial

Cecilie Petersen*, Frederik C. Loft, Eske K. Aasvang, Morten Vester-Andersen, Lars S. Rasmussen, Jørn Wetterslev, Lars N. Jorgensen, Robin Christensen, Christian S. Meyhoff

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Background: Myocardial injury after non-cardiac surgery occurs in a high number of patients, resulting in increased mortality in the post-operative period. The use of high inspiratory oxygen concentrations may cause hyperoxia, which is associated with impairment of coronary blood flow. Furthermore, the surgical stress response increases reactive oxygen species, which is involved in several perioperative complications including myocardial injury and death. Avoidance of hyperoxia and substitution of reactive oxygen species scavengers may be beneficial. Our primary objective is to examine the effect of oxygen and added antioxidants for prevention of myocardial injury assessed by area under the curve for troponin measurements during the first three post-operative days. Methods: The VIXIE trial (VitamIn and oXygen Interventions and cardiovascular Events) is an investigator-initiated, blinded, 2 × 2 factorial multicentre clinical trial. We include 600 patients with cardiovascular risk factors undergoing major non-cardiac surgery. Participants are randomised to an inspiratory oxygen fraction of 0.80 or 0.30 during and for 2 hours after surgery and either an intravenous bolus of vitamin C and an infusion of N-acetylcysteine or matching placebo of both. The primary outcome is the area under the curve for high-sensitive cardiac troponin release during the first three post-operative days as a marker of the extent of myocardial injury. Secondary outcomes are mortality, non-fatal myocardial infarction and non-fatal serious adverse events within 30 days. Perspective: The current trial will provide further evidence for clinicians on optimal administration of perioperative oxygen in surgical patients with cardiovascular risks and the clinical effects of two common antioxidants.

OriginalsprogEngelsk
TidsskriftActa Anaesthesiologica Scandinavica
Vol/bind64
Udgave nummer3
Sider (fra-til)400-409
ISSN0001-5172
DOI
StatusUdgivet - mar. 2020

Fingeraftryk

Hyperoxia
Randomized Controlled Trials
Oxygen
Wounds and Injuries
Area Under Curve
Reactive Oxygen Species
Acetylcysteine
Vitamins
Multicenter Studies
Placebos
Research Personnel
Clinical Trials

Citer dette

Petersen, Cecilie ; Loft, Frederik C. ; Aasvang, Eske K. ; Vester-Andersen, Morten ; Rasmussen, Lars S. ; Wetterslev, Jørn ; Jorgensen, Lars N. ; Christensen, Robin ; Meyhoff, Christian S. / Hyperoxia and antioxidants during major non-cardiac surgery and risk of cardiovascular events : Protocol for a 2 × 2 factorial randomised clinical trial. I: Acta Anaesthesiologica Scandinavica. 2020 ; Bind 64, Nr. 3. s. 400-409.
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title = "Hyperoxia and antioxidants during major non-cardiac surgery and risk of cardiovascular events: Protocol for a 2 × 2 factorial randomised clinical trial",
abstract = "Background: Myocardial injury after non-cardiac surgery occurs in a high number of patients, resulting in increased mortality in the post-operative period. The use of high inspiratory oxygen concentrations may cause hyperoxia, which is associated with impairment of coronary blood flow. Furthermore, the surgical stress response increases reactive oxygen species, which is involved in several perioperative complications including myocardial injury and death. Avoidance of hyperoxia and substitution of reactive oxygen species scavengers may be beneficial. Our primary objective is to examine the effect of oxygen and added antioxidants for prevention of myocardial injury assessed by area under the curve for troponin measurements during the first three post-operative days. Methods: The VIXIE trial (VitamIn and oXygen Interventions and cardiovascular Events) is an investigator-initiated, blinded, 2 × 2 factorial multicentre clinical trial. We include 600 patients with cardiovascular risk factors undergoing major non-cardiac surgery. Participants are randomised to an inspiratory oxygen fraction of 0.80 or 0.30 during and for 2 hours after surgery and either an intravenous bolus of vitamin C and an infusion of N-acetylcysteine or matching placebo of both. The primary outcome is the area under the curve for high-sensitive cardiac troponin release during the first three post-operative days as a marker of the extent of myocardial injury. Secondary outcomes are mortality, non-fatal myocardial infarction and non-fatal serious adverse events within 30 days. Perspective: The current trial will provide further evidence for clinicians on optimal administration of perioperative oxygen in surgical patients with cardiovascular risks and the clinical effects of two common antioxidants.",
author = "Cecilie Petersen and Loft, {Frederik C.} and Aasvang, {Eske K.} and Morten Vester-Andersen and Rasmussen, {Lars S.} and J{\o}rn Wetterslev and Jorgensen, {Lars N.} and Robin Christensen and Meyhoff, {Christian S.}",
year = "2020",
month = "3",
doi = "10.1111/aas.13518",
language = "English",
volume = "64",
pages = "400--409",
journal = "Acta Anaesthesiologica Scandinavica",
issn = "0001-5172",
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Hyperoxia and antioxidants during major non-cardiac surgery and risk of cardiovascular events : Protocol for a 2 × 2 factorial randomised clinical trial. / Petersen, Cecilie; Loft, Frederik C.; Aasvang, Eske K.; Vester-Andersen, Morten; Rasmussen, Lars S.; Wetterslev, Jørn; Jorgensen, Lars N.; Christensen, Robin; Meyhoff, Christian S.

I: Acta Anaesthesiologica Scandinavica, Bind 64, Nr. 3, 03.2020, s. 400-409.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Hyperoxia and antioxidants during major non-cardiac surgery and risk of cardiovascular events

T2 - Protocol for a 2 × 2 factorial randomised clinical trial

AU - Petersen, Cecilie

AU - Loft, Frederik C.

AU - Aasvang, Eske K.

AU - Vester-Andersen, Morten

AU - Rasmussen, Lars S.

AU - Wetterslev, Jørn

AU - Jorgensen, Lars N.

AU - Christensen, Robin

AU - Meyhoff, Christian S.

PY - 2020/3

Y1 - 2020/3

N2 - Background: Myocardial injury after non-cardiac surgery occurs in a high number of patients, resulting in increased mortality in the post-operative period. The use of high inspiratory oxygen concentrations may cause hyperoxia, which is associated with impairment of coronary blood flow. Furthermore, the surgical stress response increases reactive oxygen species, which is involved in several perioperative complications including myocardial injury and death. Avoidance of hyperoxia and substitution of reactive oxygen species scavengers may be beneficial. Our primary objective is to examine the effect of oxygen and added antioxidants for prevention of myocardial injury assessed by area under the curve for troponin measurements during the first three post-operative days. Methods: The VIXIE trial (VitamIn and oXygen Interventions and cardiovascular Events) is an investigator-initiated, blinded, 2 × 2 factorial multicentre clinical trial. We include 600 patients with cardiovascular risk factors undergoing major non-cardiac surgery. Participants are randomised to an inspiratory oxygen fraction of 0.80 or 0.30 during and for 2 hours after surgery and either an intravenous bolus of vitamin C and an infusion of N-acetylcysteine or matching placebo of both. The primary outcome is the area under the curve for high-sensitive cardiac troponin release during the first three post-operative days as a marker of the extent of myocardial injury. Secondary outcomes are mortality, non-fatal myocardial infarction and non-fatal serious adverse events within 30 days. Perspective: The current trial will provide further evidence for clinicians on optimal administration of perioperative oxygen in surgical patients with cardiovascular risks and the clinical effects of two common antioxidants.

AB - Background: Myocardial injury after non-cardiac surgery occurs in a high number of patients, resulting in increased mortality in the post-operative period. The use of high inspiratory oxygen concentrations may cause hyperoxia, which is associated with impairment of coronary blood flow. Furthermore, the surgical stress response increases reactive oxygen species, which is involved in several perioperative complications including myocardial injury and death. Avoidance of hyperoxia and substitution of reactive oxygen species scavengers may be beneficial. Our primary objective is to examine the effect of oxygen and added antioxidants for prevention of myocardial injury assessed by area under the curve for troponin measurements during the first three post-operative days. Methods: The VIXIE trial (VitamIn and oXygen Interventions and cardiovascular Events) is an investigator-initiated, blinded, 2 × 2 factorial multicentre clinical trial. We include 600 patients with cardiovascular risk factors undergoing major non-cardiac surgery. Participants are randomised to an inspiratory oxygen fraction of 0.80 or 0.30 during and for 2 hours after surgery and either an intravenous bolus of vitamin C and an infusion of N-acetylcysteine or matching placebo of both. The primary outcome is the area under the curve for high-sensitive cardiac troponin release during the first three post-operative days as a marker of the extent of myocardial injury. Secondary outcomes are mortality, non-fatal myocardial infarction and non-fatal serious adverse events within 30 days. Perspective: The current trial will provide further evidence for clinicians on optimal administration of perioperative oxygen in surgical patients with cardiovascular risks and the clinical effects of two common antioxidants.

U2 - 10.1111/aas.13518

DO - 10.1111/aas.13518

M3 - Journal article

C2 - 31849040

AN - SCOPUS:85077147680

VL - 64

SP - 400

EP - 409

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 3

ER -