Pre-operative Evaluation of Kidney & Pancreas Transplant Patients

NCT ID: NCT00580437

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-02
• Study Completion Date: 2012-04-01

Brief Summary

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.

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).

Conditions

Kidney Transplantation; Pancreas Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1

stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition

Group Type: EXPERIMENTAL

Dobutamine Stress Echocardiogram

Intervention Type: PROCEDURE

stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition

Interventions

Dobutamine Stress Echocardiogram

stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition

Intervention Type: PROCEDURE

Other Intervention Names

Definity; Optison

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas R Porter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0142-03-EP

Identifier Type: -

Identifier Source: org_study_id