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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00549419
Recruitment Status : Completed
First Posted : October 25, 2007
Last Update Posted : December 23, 2009
Information provided by:
Klinikum Ludwigshafen

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.

Condition or disease Intervention/treatment Phase
Major Abdominal Surgery Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine Drug: Goal-directed hemodynamic therapy Drug: Standard of care Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery
Study Start Date : October 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: 1
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
Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Active Comparator: 2 Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
The Control group will be assessed using the standard care of traditional vital signs

Drug: Standard of care
Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Primary Outcome Measures :
  1. The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate. [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00549419

Klinikum Ludwigshafen
Ludwigshafen, RLP, Germany, 67063
Sponsors and Collaborators
Klinikum Ludwigshafen
Study Director: Stefan W. Suttner, M.D. Ph.D. Klinikum Ludwigshafen

Responsible Party: Stefan Suttner, Klinikum Ludwigshafen Identifier: NCT00549419     History of Changes
Other Study ID Numbers: 2007-06
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiotonic Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Protective Agents
Plasma Substitutes
Blood Substitutes