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NCT Number: NCT03366857

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

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.

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Key information

Conditions

Supplemental Oxygen Brain Natriuretic Peptide Cardiac Risk Patients periOperative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

  • 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%

Treatment and study plan

Oxygen 30 %

Drug

The oxygen concentration will be set at 30%.

Oxygen 80 %

Drug

The oxygen concentration will be set at 80%.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Measurement of the Redox status using the RedoxSYS(R) system

  2. Copeptin

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

    Perioperative plasma Copeptin concentration

  3. MINS (myocardial ischemia after noncardiac surgery)

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

    Troponin T (TnT) measurement

  4. vWF (von Willebrand factor) Antigen

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

    Effect of supplemental oxygen on inflammatory response using von Willebrand factor antigen

  5. Fluid measurement

    Time frame: Intraoperative

    Due to the peripheral vasoconstriction of hyperoxia we measure the needed fluid for hemodynamic stability

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 8, 2017
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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