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

Sponsored by:	Klinikum Ludwigshafen
Information provided by:	Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:	NCT00549419

Purpose

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.

Condition	Intervention	Phase
Major Abdominal Surgery	Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine	Phase IV

MedlinePlus related topics: Surgery

Drug Information available for: Lactic acid Norepinephrine Dobutamine Dobutamine hydrochloride Dobutamine tartrate Dobutamine lactobionate Norepinephrine bitartrate Ammonium lactate Ringer's lactate Starch Hetastarch

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:

The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate. [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental In the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making.	Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
2: Active Comparator	Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine The Control group will be assessed using the standard care of traditional vital signs Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549419

Contacts

Contact: Stefan W. Suttner, M.D. PhD	+49-621-503 ext 3000	suttner@gmx.de
Contact: Joachim Boldt, M.D. PhD	+49-621-503 ext 3000	boldtj@gmx.net

Locations

Germany, RLP
Klinikum Ludwigshafen	Recruiting
Ludwigshafen, RLP, Germany, 67063
Contact: Stefan W. Suttner, M.D. Ph.D. +49-621-503 ext 3000 suttner@gmx.de
Principal Investigator: Stefan W. Suttner, M.D. Ph.D.

Sponsors and Collaborators

Klinikum Ludwigshafen

Investigators

Study Director:

Stefan W. Suttner, M.D. Ph.D.

Klinikum Ludwigshafen

More Information

No publications provided

Responsible Party:	Klinikum Ludwigshafen ( Stefan Suttner )
Study ID Numbers:	2007-06
Study First Received:	October 23, 2007
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00549419 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Adrenergic Agents
Norepinephrine
Vasoconstrictor Agents

Peripheral Nervous System Agents
Cardiovascular Agents
Hetastarch
Plasma Substitutes
Adrenergic Agonists
Dobutamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Cardiotonic Agents
Sympathomimetics
Hematologic Agents
Physiological Effects of Drugs
Hetastarch
Cardiovascular Agents

Protective Agents
Dobutamine
Pharmacologic Actions
Adrenergic Agonists
Autonomic Agents
Therapeutic Uses
Blood Substitutes
Norepinephrine
Vasoconstrictor Agents
Peripheral Nervous System Agents
Plasma Substitutes

ClinicalTrials.gov processed this record on May 07, 2009