Effect of Supplemental Oxygen on Perioperative BNP Concentration in Cardiac Risk Patients

Medical University of Vienna260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

260

Conditions

Supplemental Oxygen Brain Natriuretic Peptide Cardiac Risk Patients Perioperative

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

Outcomes

Primary Outcomes

Change of Postoperative Brain Natriuretic Peptide (BNP) concentration compared to preoperative baseline measurement during hospitalization

Perioperative BNP Concentration

Time frame: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 and within 72 hours before hospital discharge

Secondary Outcomes

Redox Status - sORP (static oxidation-reduction potential), cORP (capacity oxidation-reduction potential)

Measurement of the Redox status using the RedoxSYS(R) system

Time frame: 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

Copeptin

Perioperative plasma Copeptin concentration

Time frame: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3

MINS (myocardial ischemia after noncardiac surgery)

Troponin T (TnT) measurement

Time frame: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3

vWF (von Willebrand factor) Antigen

Effect of supplemental oxygen on inflammatory response using von Willebrand factor antigen

Time frame: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3

Fluid measurement

Due to the peripheral vasoconstriction of hyperoxia we measure the needed fluid for hemodynamic stability

Time frame: Intraoperative

Effect of Supplemental Oxygen on Perioperative BNP Concentration in Cardiac Risk Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes