Evaluation of BNP Values in Major Vascular Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Incidence of cardiac events
研究概览
简要总结
Background and rationale of the study:
Patients undergoing non-cardiac major surgery show a perioperative cardiac risk and postoperative complications, that can be stratified based on parameters linked to patient's conditions and to surgery types.
An accurate identification of this risk could offer numerous advantages for these patients, who's 30-day mortality is around 2%. The identification of the correct risk could lead to a better pre- and postoperative management, that could guarantee a better surgery outcome and a faster postoperative recovery.
To this day there is no perfect method to correctly estimate this risk. Various studies show that high BNP levels are linked to cardiac events at 30 and 180 days. Further investigations identify different groups, at low, intermediate and high risk, based on BNP levels.
BNP is released by ventricular myocytes in response to a wall distress, due to an increased volume, pressure or myocardial ischemia.
So BNP plasma levels could be used as a prognostic and diagnostic marker, improving the cardiac risk stratification in patients undergoing surgery and a much more precise management.
This study is determined to do an evaluation of the correlations between pre- and postoperative BNP levels and the incidence of cardiac events in patients undergoing major vascular surgery.
详细描述
Patient's informed consent signature for adhesion at the study will be initially requested. With their acceptance, parameters will be recorded anonymously in the Case Report Form, identified by their initials and a numeric code, until hospital discharge.
The parameters analyzed will be related to:
- preoperative evaluation: anamnesis, health general conditions, METs, preoperative monitoring, in particularly BNP basal levels;
- intraoperative evaluation: intraoperative monitoring;
- postoperative evaluation: BNP and cTnI levels at 24 and 48 hours, and about pulmonary, cardiovascular, neurological and surgical postoperative complications, based on the medical record.
The data will be transferred on Excel worksheet, utilized for descriptive analysis related at every variable.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Ability to provide an informed consent
- •Age >18 years old
- •Elective abdominal aortic aneurysm surgery
排除标准
- •Emergency surgery
- •Age ˂ 18 years old
- •Creatinine >2mg/dl
- •Diseases of ascending aorta, aortic arch or thoracic aorta
- •Chronic atrial fibrillation
- •Patient refusal to provide informed consent
结局指标
主要结局
Incidence of cardiac events
时间窗: from the induction of general anesthesia until hospital discharge, an average of 1 week
次要结局
- Incidence of mortality(from immediately after surgery until hospital discharge, an average of 1 week)
- Incidence of postoperative neurological complication(from immediately after surgery until hospital discharge, an average of 1 week)
- Incidence of postoperative pulmonary complication(from immediately after surgery until hospital discharge, an average of 1 week)
- Incidence of postoperative acute kidney failure(from immediately after surgery until hospital discharge, an average of 1 week)
- Incidence of unplanned ICU admission(from immediately after surgery until hospital discharge, an average of 1 week)
- Hospital length of stay(from immediately after surgery until hospital discharge, an average of 1 week)
研究者
Elena Giovanna Bignami
Clinical Professor
University of Parma