Pre-operative Evaluation of Kidney & Pancreas Transplant Patients
This study is ongoing, but not recruiting participants.
Sponsor:
University of Nebraska
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00580437
First received: December 17, 2007
Last updated: August 2, 2011
Last verified: August 2011
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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: 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:
Drug Information available for:
Perflutren
Pancreatin
Dobutamine
Dobutamine hydrochloride
Pancrelipase
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 |
|---|---|
|
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:
|
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
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
No publications provided
| 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 |
| Study First Received: | December 17, 2007 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dobutamine Pancrelipase 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 Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 13, 2013