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Pre-operative Evaluation of Kidney & Pancreas Transplant Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by University of Nebraska.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580437
First Posted: December 24, 2007
Last Update Posted: August 3, 2011
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.
Information provided by:
University of Nebraska
  Purpose
Examine the clinical utility of the dobutamine stress contrast echoes and angiograms obtained routinely in the evaluation of patients prior to kidney or pancreas transplantation.

Condition Intervention
Kidney Transplantation Pancreas Transplantation Procedure: Dobutamine Stress Echocardiogram

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Analysis of Data Collected During Angiography and Dobutamine Stress Contrast Echocardiograms in the Pre-Evaluation of Kidney and Pancreas Transplant Patients

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Provide a higher sensitivity required to adequately assess risks in the pancreas/ kidney transplant evaluation [ Time Frame: I year ]

Secondary Outcome Measures:
  • Eliminate the need for costly and invasive additional procedures [ Time Frame: 1 year ]

Estimated Enrollment: 150
Study Start Date: April 2003
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition
Procedure: Dobutamine Stress Echocardiogram
stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition
Other Names:
  • Definity
  • Optison

Detailed Description:
Although there is an increasing quantity of data demonstrating the value of stress echo in risk stratifying patients for cardiac risk prior to major non-cardiac surgery, the current clinical practice utilized for assessing patients being evaluated for kidney or pancreas transplantation is both a stress echocardiogram and a coronary angiogram. This gap in opinion appears to be a concern on the part of both nephrologists, endocrinologists, and surgeons that the stress echocardiogram may miss significant angiographic disease that could result in major post-operative complications in this high-risk subgroup of patients (unstable angina, non-fatal infarction, or death).
  Eligibility

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are being evaluated for a kidney and or pancreas transplant and scheduled for a dobutamine stress echocardiogram and a coronary angiogram will be eligible to participate

Exclusion Criteria:

  • Patients with unstable angina at the time of their evaluation, or who have a severe underlying cardiomyopathy or valve disease will be excluded.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00580437


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Thomas R Porter, MD University of Nebraska
  More Information

Responsible Party: Thomas R Porter, Professor of Medicine, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00580437     History of Changes
Other Study ID Numbers: 142-03-FB
First Submitted: December 17, 2007
First Posted: December 24, 2007
Last Update Posted: August 3, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Pancrelipase
Dobutamine
Gastrointestinal Agents
Cardiotonic Agents
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