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

NCT03366857 | Completed Phase 4 DMC

• 1 other identifier: 1744/2017
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Copeptin

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

• MINS (myocardial ischemia after noncardiac surgery)

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

• vWF (von Willebrand factor) Antigen

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

• Fluid measurement

  Intraoperative

Study Arms (2)

30%

ACTIVE COMPARATOR

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

Drug: Oxygen 30 %

80%

ACTIVE COMPARATOR

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

Drug: Oxygen 80 %

Interventions

Oxygen 30 % DRUG

The oxygen concentration will be set at 30%.

30%

Oxygen 80 % DRUG

The oxygen concentration will be set at 80%.

80%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 45 years on age, which fulfill 1 or more of the following 4 criteria undergoing non-cardiac surgery:
• History of coronary artery disease
• History of peripheral arterial disease
• History of stroke OR
• 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
• Written informed consent
• 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)

You may not qualify if:

• Symptoms of infection or sepsis
• Preoperative inotropic therapy
• Patients under ICU treatment
• Oxygen dependent patients
• History of severe heart failure and/or ejection fraction \< 30%

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (8)

• 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.

  PMID: 19826023 BACKGROUND

• 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.

  PMID: 10639541 BACKGROUND

• 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.

  PMID: 16806535 BACKGROUND

• 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.

  PMID: 23528538 BACKGROUND

• Reiterer C, Fleischmann E, Kabon B, Taschner A, Kurz A, Adamowitsch N, von Sonnenburg MF, Fraunschiel M, Graf A. Hemodynamic effects of intraoperative 30% versus 80% oxygen concentrations: an exploratory analysis. Front Med (Lausanne). 2023 May 30;10:1200223. doi: 10.3389/fmed.2023.1200223. eCollection 2023.

  PMID: 37324125 DERIVED

• 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.

  PMID: 34856530 DERIVED

• 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.

  PMID: 34087659 DERIVED

• 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.

  PMID: 32398119 DERIVED

Study Officials

• Edith Fleischmann, Prof. Dr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants don´t know the randomized oxygen concentration. The postoperative follow up will be performed by a blinded research fellow.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. univ.

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: December 8, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: May 30, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

AU (1)