Effect of Supplemental Oxygen on Perioperative Brain Natriuretic Peptide Concentration in Cardiac Risk Patients - A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change of Postoperative Brain Natriuretic Peptide (BNP) concentration compared to preoperative baseline measurement during hospitalization
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants don´t know the randomized oxygen concentration. The postoperative follow up will be performed by a blinded research fellow.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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%
研究组 & 干预措施
30%
Participants allocated to these groups will receive a FiO2 of 0.3 during the operation and for two hours postoperatively.
干预措施: Oxygen 30 % (Drug)
80%
Participants allocated to these groups will receive a FiO2 of 0.8 during the operation and for two hours postoperatively.
干预措施: Oxygen 80 % (Drug)
结局指标
主要结局
Change of Postoperative Brain Natriuretic Peptide (BNP) concentration compared to preoperative baseline measurement during hospitalization
时间窗: Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 and within 72 hours before hospital discharge
Perioperative BNP Concentration
次要结局
- Fluid measurement(Intraoperative)
- 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)
- vWF (von Willebrand factor) Antigen(Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3)
- 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)
研究者
Christian Reiterer
Dr. med. univ.
Medical University of Vienna