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

This study has been completed.
Sponsor:
Information provided by:
Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:
NCT00549419
First received: October 23, 2007
Last updated: December 21, 2009
Last verified: January 2009
History of Changes
  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
Drug: Goal-directed hemodynamic therapy
Drug: Standard of care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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

  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

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

No publications provided

Responsible Party: Stefan Suttner, Klinikum Ludwigshafen
ClinicalTrials.gov Identifier: NCT00549419     History of Changes
Other Study ID Numbers: 2007-06
Study First Received: October 23, 2007
Last Updated: December 21, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dobutamine
Norepinephrine
Hetastarch
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Vasoconstrictor Agents
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on May 16, 2013