Supplemental OxygenPhase 4NCT03366857
Effect of Supplemental Oxygen on Perioperative BNP Concentration in Cardiac Risk Patients
A Phase 4 study testing Oxygen 30 % and Oxygen 80 % in people with Supplemental Oxygen and Brain Natriuretic Peptide, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supplemental Oxygen, Brain Natriuretic Peptide, Cardiac Risk Patients
- What is being tested?
- Oxygen 30 % and Oxygen 80 %
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2017to 30 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Further inclusion criteria are:
- 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)
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Oxygen 30 %, Oxygen 80 %
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen 30 %Drug
The oxygen concentration will be set at 30%.
Oxygen 80 %Drug
The oxygen concentration will be set at 80%.
| Study group | Role | What they receive |
|---|---|---|
| 30% | Active comparator | Participants allocated to these groups will receive a FiO2 of 0.3 during the operation and for two hours postoperatively. Receives: 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. Receives: Drug: Oxygen 80 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Postoperative Brain Natriuretic Peptide (BNP) concentration compared to preoperative baseline measurement during hospitalization
Perioperative BNP Concentration
Measured: 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)
Measurement of the Redox status using the RedoxSYS(R) system
Measured: 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
Measured: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3
MINS (myocardial ischemia after noncardiac surgery)
Troponin T (TnT) measurement
Measured: 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
Measured: 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
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Supplemental OxygenStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Reiterer, Medical University of Vienna
- Investigators
- Edith Fleischmann, Prof. Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366857
- Sponsor's protocol ID
- 1744/2017
- Status last verified
- Jun 2020
- First submitted
- 2 Dec 2017
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19826023Greif 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.
PubMed 10639541Shigemitsu 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.
PubMed 16806535Rodseth 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.
PubMed 23528538Reiterer 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.
PubMed 37324125Reiterer 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.
PubMed 34856530Reiterer 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.
PubMed 34087659Reiterer 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.
PubMed 32398119
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplemental Oxygen on Perioperative Brain Natriuretic Peptide Concentration in Cardiac Risk Patients - A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03366857
- Acronym / sponsor ID
- 1744/2017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30% | Active comparator | Drug: Oxygen 30 %Participants allocated to these groups will receive a FiO2 of 0.3 during the operation and for two hours postoperatively. |
| 80% | Active comparator | Drug: Oxygen 80 %Participants allocated to these groups will receive a FiO2 of 0.8 during the operation and for two hours postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen 30 %The oxygen concentration will be set at 30%. | Drug | 30% |
| Oxygen 80 %The oxygen concentration will be set at 80%. | Drug | 80% |
Primary outcome
Change of Postoperative Brain Natriuretic Peptide (BNP) concentration compared to preoperative baseline measurement during hospitalization
Time frame: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 and within 72 hours before hospital discharge
Perioperative BNP Concentration
5 secondary outcomes
Redox Status - sORP (static oxidation-reduction potential), cORP (capacity oxidation-reduction potential)
Time frame: 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
Time frame: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3
MINS (myocardial ischemia after noncardiac surgery)
Time frame: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3
vWF (von Willebrand factor) Antigen
Time frame: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3
Fluid measurement
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Background: PubMed 19826023Meyhoff 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.
- Background: PubMed 10639541Greif 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.
- Background: PubMed 16806535Shigemitsu 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.
- Background: PubMed 23528538Rodseth 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.
- Derived from this study: PubMed 37324125Reiterer 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.
- Derived from this study: PubMed 34856530Reiterer 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.
- Derived from this study: PubMed 34087659Reiterer 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.
- Derived from this study: PubMed 32398119Reiterer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith Fleischmann, Prof. Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxygen 30 % and Oxygen 80 % in people with Supplemental Oxygen and Brain Natriuretic Peptide, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Postoperative Brain Natriuretic Peptide (BNP) concentration compared to preoperative baseline measurement during hospitalization (time frame: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 and within 72 hours before hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03366857, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.