Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Abdominal Surgery
Information source: Klinikum Ludwigshafen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Abdominal Surgery
Intervention: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine (Drug); Goal-directed hemodynamic therapy (Drug); Standard of care (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Klinikum Ludwigshafen Official(s) and/or principal investigator(s):
Stefan W. Suttner, M.D. Ph.D., Study Director, Affiliation: Klinikum Ludwigshafen
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.
Clinical Details
Official title: Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.
Secondary outcome: Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Klinikum Ludwigshafen, Ludwigshafen, RLP 67063, Germany
Additional Information
Starting date: October 2007
Last updated: December 21, 2009
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