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

Effect of Supplemental Oxygen on Perioperative Brain Natriuretic Peptide Concentration in Cardiac Risk Patients - A Prospective Randomized Clinical Trial

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 Overview

• Status: Completed
• Conditions: Perioperative; Brain Natriuretic Peptide; Supplemental Oxygen; Cardiac Risk Patients
• Intervention / Treatment: Drug: Oxygen 30 %; Drug: Oxygen 80 %

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 30%; Participants allocated to these groups will receive a FiO2 of 0.3 during the operation and for two hours postoperatively.	Drug: Oxygen 30 %; The oxygen concentration will be set at 30%.
Active Comparator: 80%; Participants allocated to these groups will receive a FiO2 of 0.8 during the operation and for two hours postoperatively.	Drug: Oxygen 80 %; The oxygen concentration will be set at 80%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Postoperative Brain Natriuretic Peptide (BNP) concentration compared to preoperative baseline measurement during hospitalization	Perioperative BNP Concentration	Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 and within 72 hours before hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Redox Status - sORP (static oxidation-reduction potential), cORP (capacity oxidation-reduction potential)	Measurement of the Redox status using the RedoxSYS(R) system	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	Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3
MINS (myocardial ischemia after noncardiac surgery)	Troponin T (TnT) measurement	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	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	Intraoperative

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Edith Fleischmann, Prof. Dr., Medical University of Vienna

Publications and helpful links

General Publications

• Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.
• Rodseth RN, Biccard BM, Chu R, Lurati Buse GA, Thabane L, Bakhai A, Bolliger D, Cagini L, Cahill TJ, Cardinale D, Chong CP, Cnotliwy M, Di Somma S, Fahrner R, Lim WK, Mahla E, Le Manach Y, Manikandan R, Pyun WB, Rajagopalan S, Radovic M, Schutt RC, Sessler DI, Suttie S, Vanniyasingam T, Waliszek M, Devereaux PJ. Postoperative B-type natriuretic peptide for prediction of major cardiac events in patients undergoing noncardiac surgery: systematic review and individual patient meta-analysis. Anesthesiology. 2013 Aug;119(2):270-83. doi: 10.1097/ALN.0b013e31829083f1.
• Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.
• Shigemitsu M, Nishio K, Kusuyama T, Itoh S, Konno N, Katagiri T. Nocturnal oxygen therapy prevents progress of congestive heart failure with central sleep apnea. Int J Cardiol. 2007 Feb 14;115(3):354-60. doi: 10.1016/j.ijcard.2006.03.018. Epub 2006 Jun 23.
• Reiterer C, Fleischmann E, Taschner A, Adamowitsch N, von Sonnenburg MF, Graf A, Fraunschiel M, Starlinger P, Goschin J, Kabon B. Perioperative supplemental oxygen and oxidative stress in patients undergoing moderate- to high-risk major abdominal surgery - A subanalysis of randomized clinical trial. J Clin Anesth. 2022 May;77:110614. doi: 10.1016/j.jclinane.2021.110614. Epub 2021 Nov 29.
• Reiterer C, Kabon B, Taschner A, Falkner von Sonnenburg M, Graf A, Adamowitsch N, Starlinger P, Goshin J, Fraunschiel M, Fleischmann E. Perioperative supplemental oxygen and NT-proBNP concentrations after major abdominal surgery - A prospective randomized clinical trial. J Clin Anesth. 2021 Oct;73:110379. doi: 10.1016/j.jclinane.2021.110379. Epub 2021 Jun 1. Erratum In: J Clin Anesth. 2022 Feb;76:110579.
• Reiterer C, Kabon B, von Sonnenburg MF, Starlinger P, Taschner A, Zotti O, Goshin J, Drlicek G, Fleischmann E. The effect of supplemental oxygen on perioperative brain natriuretic peptide concentration in cardiac risk patients - a protocol for a prosprective randomized clinical trial. Trials. 2020 May 12;21(1):400. doi: 10.1186/s13063-020-04336-9.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: December 2, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1744/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No