Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Variation from basal of the levels of biomarkers of brain, heart, kidney and endothelial injury.
研究概览
简要总结
Intraoperative hypotension (defined as mean arterial pressure below 65 mmHg) is associated with increased organs dysfunction and mortality. Even short durations of reduced arterial blood pressure episodes significantly increased the risk of myocardial injury, neurological deficits, renal failure, and mortality. Hypotension rate during surgery is quite common and recent studies showed an incidence up to 60% of patients endured hypotension during anesthesia for an average of 10% of surgical time.
Nowadays hypotension seems to be preventable even if current management of the hypotensive episodes is predominantly reactive and rather occurs with some delay.
The investigators hypothesize that the prevention of hypotension by means Edwards Lifesciences new technology (HPI software) can improve patients outcome after surgery.
The present pilot randomized clinical trial is aimed at investigating various biomarkers involved in organ dysfunction and how they correlate with different intraoperative hypotension management strategies (Invasive blood pressure monitored by a normal arterial line vs Invasive blood pressure monitored by Edwards FloTracIQ system with HPI software).
详细描述
The primary objective of this pilot study is to investigate if an early treatment of intraoperative hypotension driven by an Edwards Lifesciences new technology (Hypotension Probability Index - HPI software) and integrated hemodynamic variables is able to determine a modification of the blood levels of several specific biomarkers of tissue and organ damage compared to a traditional management of hypotension. It will also be evaluated if the management strategy of patient hemodynamics based on the Hypotension Probability Index (HPI) is associated with a lower incidence of hypotensive events and / or a shorter overall duration of intraoperative hypotension.
In the study will be enrolled forty adult patients requiring an arterial line (at discretion of treating physician) undergoing non-cardiac non-day surgery (with an expected duration of more than 2 hours and an aimed medium arterial pressure - MAP of 65 mmHg) at the Universitary Hospital of Catania.
The patients will be randomly (1:1) assigned to one of the subsequent two groups: a group monitored with FloTracIQ with HPI software (Treatment Group) and a group with standard invasive blood pressure monitoring (Control Group).
In the Control Group, all hypotensive episodes during surgery will be treated according to standard of care.
Patients randomized to the Treatment Group will receive monitoring with integration of HPI index and hemodynamic parameters visible on the EV1000 platform; these informations will be used to guide the investigator in the choice of the more appropriate treatment to be carried out. The value of HPI is updated every 20 seconds and expresses in percentage the probability of occurrence of a hypotensive event. The cut-off value of HPI is equal to 85%. Values above the cut-off are related to a higher probability of hypotension. A specific visual and sound "ALERT" will indicate to the investigator if the threshold value is reached / exceeded. Any treatment strategy will be based on integrated analysis of clinical and instrumental data showed on the screen of the EV1000 platform [MAP, cardiac output (CO), systemic vascular resistance (SVR), stroke volume (SV), stroke volume variation (SVV), intra-ventricular pressure rate of rise (dP/dt), dynamic arterial elastance (Eadyn)].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older;
- •Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours;
- •Planned to receive general anesthesia;
- •Planned to receive an arterial line during surgery;
- •Aim for MAP of 65 mmHg during surgery;
- •Being able to give written informed consent prior to surgery.
排除标准
- •Age less than 18 years;
- •Aim for MAP other than 65 mmHg at discretion treating physician;
- •Significant hypotension before surgery defined as a MAP <65;
- •Right- or left sided cardiac failure [e.g. left ventricular ejection fraction (LVEF)<35%];
- •Known cardiac shunts (significant);
- •Known aortic stenosis (severe);
- •Severe cardiac arrhythmias including atrial fibrillation;
- •Chronic kidney disease (as chronic kidney disease may affect the interpretation and prognostic significance of changes in urinary biomarkers);
- •Liver surgery;
- •Vascular surgery with clamping of the aorta;
- •Diabetes.
结局指标
主要结局
Variation from basal of the levels of biomarkers of brain, heart, kidney and endothelial injury.
时间窗: End of surgical procedures
The following biomarkers will be assessed: neuron specific enolase and S100B (for brain monitoring); high sensitive cardiac troponin T (for heart monitoring); Neutrophil Gelatinase-Associated Lipocalin (NGAL, for kidney monitoring); circulating endothelial cells counting and cytofluorimetric analysis (for endothelial monitoring).Systemic effects of intraoperative hypotension will be determine by measuring inflammatory cytokines (IL-6, IL-1 beta and TNF-alfa), oxidative stress biomarkers (reduced glutathione, lipid hydroperoxides) and markers of hypoxia (HIF1alpha, lactate, acetylCoA, CoA).
次要结局
- Incidence of hypotension during surgery(End of surgical procedures)
- Time spent in hypotension during surgery(End of surgical procedures)
- Patient-reported outcomes(30 days postsurgical procedure)
研究者
Paolo Murabito
Assistant Professor
University of Catania