Perioperative Clinical Trial
Official title:
Effect of Supplemental Oxygen on Perioperative Brain Natriuretic Peptide Concentration in Cardiac Risk Patients - A Prospective Randomized Clinical Trial
Verified date | June 2020 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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% |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
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
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 |
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