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

This study has been completed.
Information provided by:
Klinikum Ludwigshafen Identifier:
First received: October 23, 2007
Last updated: December 21, 2009
Last verified: January 2009
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 Drug: Goal-directed hemodynamic therapy Drug: Standard of care Phase 4

Study Type: Interventional
Study Design: 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

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 ]

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 ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT00549419

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

Responsible Party: Stefan Suttner, Klinikum Ludwigshafen Identifier: NCT00549419     History of Changes
Other Study ID Numbers: 2007-06
Study First Received: October 23, 2007
Last Updated: December 21, 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 processed this record on September 21, 2017