Pre-operative Evaluation of Kidney & Pancreas Transplant Patients - Full Text View

Sponsor:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00580437

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:	Diagnostic, Open Label, Single Group Assignment
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:

MedlinePlus related topics: Kidney Transplantation Pancreas Transplantation

Drug Information available for: Dobutamine Dobutamine hydrochloride Dobutamine tartrate Dobutamine lactobionate

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Eliminate the need for costly and invasive additional procedures [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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
Arm 1: Experimental 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

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

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580437

Contacts

Contact: Thomas R Porter, MD	402-559-7977	trporter@unmc.edu
Contact: Brian R Stevens, MD, PhD		rbstevens@unmc.edu

Locations

United States, Nebraska
University of Nebraska Medical Center	Recruiting
Omaha, Nebraska, United States, 68105
Contact: Saritha Dodla, MD 402-559-7271 sdodla@unmc.edu
Contact: Stacey L Kearney, BS 402-559-7977 skearney@unmc.edu
Principal Investigator: Thomas R Porter, MD

Sponsors and Collaborators

University of Nebraska

Investigators

Principal Investigator:

Thomas R Porter, MD

University of Nebraska

More Information

No publications provided

Responsible Party:	University of Nebraska Medical Center ( Thomas R Porter, Professor of Medicine )
Study ID Numbers:	142-03-FB
Study First Received:	December 17, 2007
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00580437 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Adrenergic Agents
Cardiotonic Agents
Sympathomimetics
Physiological Effects of Drugs
Cardiovascular Agents

Protective Agents
Dobutamine
Pharmacologic Actions
Adrenergic Agonists
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010