Patients undergoing major non-cardiac surgery MedDRA version: 20.0 Level: HLT Classification code 10007654 Term: Cardiovascular injuries System Organ Class: 100000004863 MedDRA version: 20.0 Level: PT Classification code 10064939 Term: Cardiovascular event prophylaxis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849 MedDRA version: 20.0 Level:
Conditions
Interventions
Trade Name: Acetylcystein SAD
Product Name: Acetylcystein SAD
Pharmaceutical Form: Concentrate for emulsion for infusion
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-acetylcysteine, N
Sponsors
Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Mortality 2. Non-fatal myocardial infarction 3. Surgical site infection as defined by CDC (28) 4. Pneumonia as defined by CDC (29) 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) 6. Acute respiratory failure defined as the need for controlled ventilation or oxygen saturation of 90% or less despite of oxygen therapy. 7. Acute kidney injury (AKI) as defined Kidney Disease Improving Global Outcomes (KDIGO) guidelines (31) 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). ;Timepoint(s) of evaluation of this end point: 30 days | — |
Countries
Denmark, Sweden
Contacts
Public ContactCecilie Petersen
Bispebjerg Hospital
Outcome results
None listed