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

Perioperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366857
• Other study ID #: 1744/2017
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: May 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

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

Intervention

Drug:
• Oxygen 30 %
The oxygen concentration will be set at 30%.
• Oxygen 80 %
The oxygen concentration will be set at 80%.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (4)

Greif R, Akça 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. — View Citation

Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Høgdall 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, Heltø 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. — View Citation

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. Review. — View Citation

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. Epub 2006 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Copeptin	Perioperative plasma Copeptin concentration	Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3
Secondary	MINS (myocardial ischemia after noncardiac surgery)	Troponin T (TnT) measurement	Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3
Secondary	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
Secondary	Fluid measurement	Due to the peripheral vasoconstriction of hyperoxia we measure the needed fluid for hemodynamic stability	Intraoperative