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Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery (REPEAT)

This study is currently recruiting participants.
Verified by Klinikum Ludwigshafen, May 2008

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

ChemIDplus related topics:   Dobutamine    Dobutamine hydrochloride    Dobutamine lactobionate    Dobutamine tartrate    Starch    Hetastarch    Lactic acid    Ammonium lactate    Norepinephrine    Norepinephrine bitartrate    Ringer's lactate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

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 ]

Estimated Enrollment:   60
Study Start Date:   October 2007
Estimated Study Completion Date:   October 2008
Estimated Primary Completion Date:   July 2008 (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


Responsible Party:   Klinikum Ludwigshafen ( Stefan Suttner )
Study ID Numbers:   2007-06
First Received:   October 23, 2007
Last Updated:   May 5, 2008
ClinicalTrials.gov Identifier:   NCT00549419
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Norepinephrine
Hetastarch
Dobutamine

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

ClinicalTrials.gov processed this record on October 17, 2008




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