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

niversity Medical Center Hamburg-Eppendorf, Germany0 sites380 target enrollmentJuly 4, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: - Hemodynamic Instability- Cardiac Output- High Peroperative Complication
Sponsor: niversity Medical Center Hamburg-Eppendorf, Germany
Enrollment: 380
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

July 4, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Medical Center Hamburg-Eppendorf, Germany

•\- 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,