Individualized perioperative hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS-trial) - iPEGASUS

niversity Medical Center Hamburg-Eppendorf, Germany0 个研究点目标入组 380 人开始时间: 2017年7月4日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•- To provide high generalizability and representativeness the high number of patients with laparotomy and major surgical trauma is included into this study.
•- Therefore, open visceral, urological, and gynecological surgery is covered by this study.
•- Expected duration of surgery must be = 120 minutes and requirement of volume therapy needs to be expected = 2 liters.
•- Risk for any postoperative complications needs to be =10% assessed by the ACS (American College of Surgery)- NSQUIP (National Surgical Quality Improvement Program) risk calculator.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 380
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Patients <18 years,
•-Laparoscopic approach,
•-Patients not having sinus rhythm,
•-Patients having highly impaired left ventricular function (ejection fraction <30%) or severe aortic valve stenosis (aortic valve area <1 cm2, mean gradient >40 mmHg),
•-Pregnant women,
•-Emergency surgeries (surgery required within 24 hours),
•-Primarily vascular surgery,
•-Patients suffering from septic shock,
•-Patients having phaeochromocytoma,
•-Patients suffering from non-cardiac chest pain,
•-Refusal of consent,
•-Patients receiving palliative treatment only (likely to die within 6 months) and patients suffering from acute myocardial ischemia (within 30 days before randomization) are excluded from the study.
•-Further, in case that clinicians intended to use cardiac output monitoring for clinical reasons patients should also not be included in the study.

发起方

niversity Medical Center Hamburg-Eppendorf, Germany