Brain Natriuretic Peptide, Cardiac Risk Patients, Perioperative, Supplemental Oxygen
Conditions
Brief summary
The effect of supplemental oxygen on surgical site infections was already investigated in several studies before. Although, oxygen is one of the most used medical therapy in hospitalized patients, the influence on the cardiovascular system is still unknown. Available data indicate beneficial effects of supplemental oxygen on cardiovascular function. Because, no evidence exists concerning the perioperative period, it is our objective to investigate supplemental oxygen in cardiac risk patients undergoing major abdominal surgery. Due to the significant reduction of BNP by inhibiting sympathetic nerve activity we hypothesize that supplemental oxygen have beneficial effects in perioperative BNP release in cardiac risk patients undergoing major abdominal surgery.
Interventions
DRUGOxygen 30 %
The oxygen concentration will be set at 30%.
DRUGOxygen 80 %
The oxygen concentration will be set at 80%.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants don´t know the randomized oxygen concentration. The postoperative follow up will be performed by a blinded research fellow.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients over 45 years on age, which fulfill 1 or more of the following 4 criteria undergoing non-cardiac surgery: 1. History of coronary artery disease 2. History of peripheral arterial disease 3. History of stroke OR 4. Any of 3 of 7 A) Age ≥ 70 years B) Undergoing major surgery C) History of congestive heart failure D) History of transient ischemic attack E) Diabetes and currently taking an oral hypoglycemic agent or insulin F) History of Hypertension Further inclusion criteria are: 1. Written informed consent 2. Elective major abdominal open surgery or laparoscopically assisted procedures scheduled to take over two hours done under general anesthesia (colorectal, urology, gynecology, liver and pancreatic surgery)
Exclusion criteria
1. Symptoms of infection or sepsis 2. Preoperative inotropic therapy 3. Patients under ICU treatment 4. Oxygen dependent patients 5. History of severe heart failure and/or ejection fraction \< 30%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Postoperative Brain Natriuretic Peptide (BNP) concentration compared to preoperative baseline measurement during hospitalization | Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 and within 72 hours before hospital discharge | Perioperative BNP Concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Redox Status - sORP (static oxidation-reduction potential), cORP (capacity oxidation-reduction potential) | Preoperative, 2 hours after induction of anesthesia, postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 and within 72 hours before hospital discharge | Measurement of the Redox status using the RedoxSYS(R) system |
| Copeptin | Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 | Perioperative plasma Copeptin concentration |
| MINS (myocardial ischemia after noncardiac surgery) | Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 | Troponin T (TnT) measurement |
| vWF (von Willebrand factor) Antigen | Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 | Effect of supplemental oxygen on inflammatory response using von Willebrand factor antigen |
| Fluid measurement | Intraoperative | Due to the peripheral vasoconstriction of hyperoxia we measure the needed fluid for hemodynamic stability |
Countries
Austria
Outcome results
None listed