Comparison of Arterial Blood Pressure and Cardiac Index-based Hemodynamic Management on Postoperative Myocardial Injury in Patients Undergoing Hepatopancreatic Surgery: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative high sensitive troponin change
研究概览
简要总结
The primary aim of this study is to compare mean arterial pressure (MAP) and cardiac index (CI) based intraoperative hemodynamic management in terms of postoperative high sensitive troponin elevation.
The hypothesis of the study is that there will be at least 5ng/L difference between the two groups in terms of troponin elevation occurring in the postoperative period. When power analysis was performed with this primary output, it was calculated that while alpha was 0.05 beta 0.2, 42 patients in each group, a total of 84 patients were required.
详细描述
Fluid therapy will be started as 2-4 ml/kg/h, according to the clinician's decision for the patient. Afterwards, patients will be managed hemodynamically with one of the MAP and CI algorithms.
Targeted fluid therapy will be administered in accordance with the following definitions of normal and algorithms for both groups.
Normal definitions:
MAP: Baseline MAP +/- 20% and MAP>65mmHg Baseline MAP: MAP average in the ward at rest the day before surgery
CI: Baseline CI +/- 20% and CI > 2.2 L/m2/min Baseline CI: CI calculated by MostCare monitor before the anesthesia induction starts
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo pancreatic-hepatic surgery
- •Patients over 65 years of age or patients over 45 years of age and with at least one of the following comorbidities:
- •coronary artery disease, Congestive heart failure, moderate to severe heart valve disease, peripheral artery disease Moderate to Severe Pulmonary hypertension, cerebrovascular accident older than 1 month, History of pulmonary embolism more than 1 month old, Diabetes Mellitus, Hypertension
排除标准
- •Presence of atrial fibrillation, sepsis, pulmonary embolism
- •Presence of pulmonary embolism, acute coronary syndrome and cerebrovascular accident in the last month
- •Static respiratory system compliance < 35ml/cmH2O
- •Patients with preoperative high sensitive Troponin T value >65ng/liter
- •glomerular filtration rate < 60 ml/min
- •Exclusion criteria during the protocol:
- •Newly developed arrhythmia, embolism, sepsis,
- •Cancellation of planned surgery
- •Postoperative hepatic failure defined as INR>2
结局指标
主要结局
Postoperative high sensitive troponin change
时间窗: three days
difference between the mean high sensitive troponin elevation between the groups will be evaluated. high sensitive troponin T will be measured one day before the surgery, and daily after the surgery for three days
次要结局
- 90-days mortality(90 days)
- postoperative myocardial injury incidence(three days)
研究者
Taner Abdullah
Medical Doctor
Istanbul Saglik Bilimleri University