Major Abdominal Surgery
Conditions
Brief summary
The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.
Interventions
DRUGRingers lactate, hydroxyethyl starch; norepinephrine, dobutamine
The Control group will be assessed using the standard care of traditional vital signs
Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
DRUGStandard of care
Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
Sponsors
Klinikum Ludwigshafen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is scheduled for elective major abdominal surgery and has two or more risk factors according to the Lee classification scheme. * Patient can sign informed consent before surgery. * Patient is able to comply with the study procedure. * Patient must require an indwelling radial or a femoral artery catheter. * Patient must be 20 years old or older. * Patient must be 40kg or heavier. * Patients height and weight can be accurately obtained prior to study start.
Exclusion criteria
* Emergency surgery. * Patients with aortic or mitral valve regurgitation. * Renal insufficiency requiring hemodialysis. * Liver dysfunction (alanine/aspartate aminotransferase \>40 U/L). * Patient with contraindications for the placement of radial, femoral or other arterial cannulae. * Patient being treated with an intraaortic balloon pump. * Female patients with a known pregnancy. * Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate. | 6 month |
Secondary
| Measure | Time frame |
|---|---|
| Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation) | 6 month |
Countries
Germany
Outcome results
None listed