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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Perioperative; Supplemental Oxygen; Cardiac Risk Patients; Brain Natriuretic Peptide

Treatments: Drug: Oxygen 30 %; Drug: Oxygen 80 %

Study type: Interventional

Funder types: Other

Identifiers

NCT03366857

1744/2017

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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260 participants in 2 patient groups

30%

Active Comparator group

Description:

Participants allocated to these groups will receive a FiO2 of 0.3 during the operation and for two hours postoperatively.

Treatment:

Drug: Oxygen 30 %

80%

Active Comparator group

Description:

Participants allocated to these groups will receive a FiO2 of 0.8 during the operation and for two hours postoperatively.

Treatment:

Drug: Oxygen 80 %