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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


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)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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