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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Supplemental Oxygen Brain Natriuretic Peptide Cardiac Risk Patients Perioperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants don´t know the randomized oxygen concentration. The postoperative follow up will be performed by a blinded research fellow.

Study Groups

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30%

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

Group Type ACTIVE_COMPARATOR

Oxygen 30 %

Intervention Type DRUG

The oxygen concentration will be set at 30%.

80%

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

Group Type ACTIVE_COMPARATOR

Oxygen 80 %

Intervention Type DRUG

The oxygen concentration will be set at 80%.

Interventions

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Oxygen 30 %

The oxygen concentration will be set at 30%.

Intervention Type DRUG

Oxygen 80 %

The oxygen concentration will be set at 80%.

Intervention Type DRUG

Eligibility Criteria

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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

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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No