Study of ekstra oxygen or antioxidant during anesthesia for major surgery

Phase 1

• Conditions: Patients undergoing major non-cardiac surgery; MedDRA version: 20.0Level: HLTClassification code 10007654Term: Cardiovascular injuriesSystem Organ Class: 100000004863; MedDRA version: 20.0Level: PTClassification code 10064939Term: Cardiovascular event prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10032964Term: Other symptoms involving cardiovascular systemSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10078955Term: Cardiovascular riskSystem Organ Class: 100000004869; MedDRA version: 20.0Level: PTClassification code 10052616Term: Intraoperative careSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002670-39-DK
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-06
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

All of the listed criteria (1.-4.) must be met.
1. Age 45 years or above
2. Elective or acute surgery in general anaesthesia
3. Scheduled for abdominal, orthopaedic, or vascular surgery with expected surgery duration of one hour or more.
4. Fulfil any 1 of the following 5 criteria:
a)- History of coronary artery disease including angina
b)- History of stroke
c)- Undergoing vascular surgery
d)- History of peripheral arterial disease
e)- Any 2 of the following 7 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Pregnant women will be excluded. A routine HCG will not be measured, if women are 50 years or older. Preoperative inability to give informed consent, arterial oxygen saturation (SpO2) below 90% without oxygen supplementation before surgery; drug allergy involving any of the interventional drugs; surgery within 30 days of operation; previous use of bleomycin due to the risk of pulmonary fibrosis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the benefits and harms of perioperative hyperoxia and antioxidant treatment.;Secondary Objective: Assess specific cardiovasvular complications in these patients;Primary end point(s): MINS, as assessed by area under the curve (AUC) for high-sensitive Troponin-T or Troponin-I measured the first 3 postoperative days. ;Timepoint(s) of evaluation of this end point: On the day of surgery and 3 days post surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Mortality<br>2. Non-fatal myocardial infarction <br>3. Surgical site infection as defined by CDC (28)<br>4. Pneumonia as defined by CDC (29)<br>5. Sepsis as defined by the joint task force by the European Society of Intensive Care Medicine and the Society of Critical Care Medicine (30)<br>6. Acute respiratory failure defined as the need for controlled ventilation or oxygen saturation of 90% or less despite of oxygen therapy. <br>7. Acute kidney injury (AKI) as defined Kidney Disease Improving Global Outcomes (KDIGO) guidelines (31)<br>8. Other serious adverse events as defined by ICH-GCP as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (32).<br>;Timepoint(s) of evaluation of this end point: 30 days