Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Abdominal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery

Conditions
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Major Abdominal Surgery

Intervention / Treatment
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* Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
* Drug: Goal-directed hemodynamic therapy
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>In the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making. | Drug: Goal-directed hemodynamic therapy<br>* Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine<br>|
| Active Comparator: 2<br> | Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine<br>* The Control group will be assessed using the standard care of traditional vital signs<br>Drug: Standard of care<br>* Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate. |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |