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

Phase 4

Completed

• Conditions: Perioperative; Supplemental Oxygen; Brain Natriuretic Peptide; Cardiac Risk Patients
• Interventions: Drug: Oxygen 30 %; Drug: Oxygen 80 %

• Registration Number: NCT03366857
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-02
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-08
• Primary Completion: 2019-12-31
• Study Completion: 2020-05-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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)

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30%	Oxygen 30 %	Participants allocated to these groups will receive a FiO2 of 0.3 during the operation and for two hours postoperatively.
80%	Oxygen 80 %	Participants allocated to these groups will receive a FiO2 of 0.8 during the operation and for two hours postoperatively.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Fluid measurement	Intraoperative	Due to the peripheral vasoconstriction of hyperoxia we measure the needed fluid for hemodynamic stability
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
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
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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria