Personalized Hemodynamic Management Targeting Preoperative Baseline Cardiac Index in High-risk Patients Having Major Abdominal Surgery: the International Multicenter Randomized PELICAN Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,128
- 试验地点
- 18
- 主要终点
- Composite outcome of major postoperative complications
研究概览
简要总结
Postoperative mortality within 30 days after surgery is around 2% in patients having major noncardiac surgery in Europe and the USA. In fact, if the first 30 days after surgery were considered a disease, it would be the third leading cause of death globally. Postoperative deaths are a consequence of postoperative organ injury and complications - including acute myocardial injury, acute kidney injury, and severe infectious complications. To avoid postoperative deaths, it is thus crucial to reduce postoperative organ injury and complications. To reduce postoperative organ injury and complications, modifiable risk factors need to be addressed. These modifiable risk factors for postoperative organ injury include low blood flow states and intraoperative hypotension. Optimizing blood flow (i.e., cardiac index) during surgery may thus be effective in reducing postoperative organ injury and complications. However, the optimal hemodynamic treatment strategy for high-risk surgical patients remains unclear. Cardiac index varies substantially between individuals. However, current intraoperative hemodynamic treatment strategies mainly aim to maximize cardiac index instead of using personalized cardiac index targets for each individual patient. A single-center pilot trial suggests that using individualized cardiac index targets during surgery may reduce postoperative organ injury and complications compared to routine hemodynamic management. However, large robust trials investigating the effect of personalized hemodynamic management targeting preoperative baseline cardiac index on postoperative complications are missing.
The investigators, therefore, propose a multicenter randomized trial to test the hypothesis that personalized intraoperative hemodynamic management targeting preoperative baseline cardiac index reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, severe infectious complications, and death within 7 days after surgery compared to routine hemodynamic management in high-risk patients having elective major abdominal surgery.
详细描述
not provided
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
In patients in the routine management group, the treating anesthesiologists will be blinded to data of preoperative baseline cardiac output measurements to avoid performance bias. Participanting patients, outcome assessors, and data analysts are blinded to group allocation.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients ≥45 years scheduled for elective major abdominal surgery (involving visceral organs) under general anesthesia that is expected to last ≥90 minutes AND presence of ≥1 of the following high-risk criteria:
- •exercise tolerance <4 metabolic equivalents as defined by the guidelines of the American College of Cardiology/American Heart Association
- •renal impairment (serum creatinine ≥1.3 mg dL-1 or estimated glomerular filtration rate <90 mL min-1 (1.73 m2)-1 within the last 6 months
- •coronary artery disease
- •chronic heart failure (New York Heart Association Functional Classification ≥II)
- •valvular heart disease (moderate or severe)
- •history of stroke
- •peripheral arterial occlusive disease (any stage)
- •chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage)
- •diabetes mellitus requiring oral hypoglycemic agent or insulin
- •immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma) or therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids [above Cushing threshold])
- •liver cirrhosis (any Child-Pugh class)
- •body mass index ≥30 kg m-2
- •history of smoking within two years of surgery
- •age ≥65 years
- •expected surgery duration ≥180 minutes
- •B-type natriuretic peptide (BNP) >80 ng/L or N-terminal B-type natriuretic peptide (NT-proBNP) >200 ng/L within the last 6 months
排除标准
- •emergency surgery
- •ambulatory surgery
- •planned surgery: nephrectomy, liver or kidney transplantation surgery
- •status post transplantation of kidney, liver, heart, or lung
- •sepsis (according to current Sepsis-3 definition)
- •American Society of Anesthesiologists physical status classification V or VI
- •pregnancy
- •impossibility to perform cardiac index monitoring using the Starling Fluid Management System (Baxter, Deerfield, IL, USA)
- •current participation in another clinical trial or treatment with a similar biological mechanism or primary outcome measure
研究组 & 干预措施
Personalized hemodynamic management (intervention)
In patients assigned to personalized hemodynamic management, intraoperative cardiac index will be maintained at least at the preoperative baseline cardiac index using a predefined treatment algorithm.
Preoperative baseline cardiac index will be determined with the patient being awake and resting in supine position using the Starling Fluid Management System (Baxter, Deerfield, IL, USA) (usually at least one day before surgery). We will define the individual preoperative baseline cardiac index as the average value over a 5 min period at rest (minimum cardiac index threshold: 2.2 L min-1 m-2).
Mean arterial blood pressure will be maintained above 65 mmHg. The study intervention will start at the beginning of surgery and will end at the end of surgery.
干预措施: Personalized hemodynamic management (Other)
Routine hemodynamic management (control)
In patients assigned to routine hemodynamic management, hemodynamic management will performed as per anesthesiologist preference. Cardiac index monitoring will be will measured using the Baxter Starling Fluid Management System (Baxter, Deerfield, IL, USA). The attending anesthesiologist will be blinded to cardiac index measurements. Cardiac index monitoring can be unblinded upon request. Mean arterial blood pressure will be maintained above 65 mmHg.
结局指标
主要结局
Composite outcome of major postoperative complications
时间窗: Postoperative Day 7
Collapsed composite ("any event versus none") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, severe infectious complications, and death within 7 days after surgery.
次要结局
- Composite outcome of major postoperative complications(Postoperative Day 3)
- Postoperative acute kidney injury(Postoperative Day 7)
- Postoperative acute myocardial injury(Postoperative Day 7)
- Postoperative severe infectious complications(Postoperative Day 7)
- Postoperative non-fatal cardiac arrest(Postoperative Day 90)
- Postoperative death(Postoperative Day 90)
- Composite outcome of long-term postoperative complications(Postoperative Day 90)
- Postoperative need for renal replacement therapy(Postoperative Day 90)
- Postoperative myocardial infarction(Postoperative Day 90)
- Postoperative fever(Postoperative Day 7)
- Postoperative respiratory infection(Postoperative Day 7)
- Postoperative neurological infection(Postoperative Day 7)
- Postoperative urinary system infection(Postoperative Day 7)
- Postoperative colitis or infection with Clostridium difficile(Postoperative Day 7)
- Postoperative endometritis(Postoperative Day 7)
- Postoperative deep incisional surgical site infection(Postoperative Day 7)
- Postoperative organ or space surgical site infection(Postoperative Day 7)
- Postoperative unknown infection with pathogenic organisms in tissue or fluid(Postoperative Day 7)
- Postoperative sepsis(Postoperative Day 7)
- Transfer from intensive care unit to normal ward(Postoperative Day 90)
- Hospital discharge(Postoperative Day 90)
- Unplanned hospital re-admission(Postoperative Day 30)
- Postoperative acute kidney injury(Postoperative Day 3)
- Postoperative acute myocardial injury(Postoperative Day 3)
- Postoperative severe infectious complications(Postoperative Day 3)
- Postoperative non-fatal cardiac arrest(Postoperative Day 3)
- Postoperative non-fatal cardiac arrest(Postoperative Day 7)
- Postoperative death(Postoperative Day 3)
- Postoperative death(Postoperative Day 7)
- Composite outcome of long-term postoperative complications(Postoperative Day 30)
- Postoperative need for renal replacement therapy(Postoperative Day 30)
- Postoperative myocardial infarction(Postoperative Day 30)
- Postoperative non-fatal cardiac arrest(Postoperative Day 30)
- Postoperative death(Postoperative Day 30)