Back to resultsCardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor
Primary Purpose
Cardiopulmonary Bypass
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir/placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cardiopulmonary Bypass
Eligibility Criteria
Inclusion Criteria:
- Any patient undergoing elective (non-emergency) cardiopulmonary bypass for coronary artery bypass grafting, cardiac valve replacement, or both.
Exclusion Criteria:
- A dozen different medical conditions and two dozen medical contraindications.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nelfinavir/placebo
Arm Description
Outcomes
Primary Outcome Measures
Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter
Secondary Outcome Measures
Changes in quantitative measure of inflammatory markers
Changes in clinical outcomes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00385450
Brief Title
Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor
Official Title
Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor in the Perioperative Period
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Study closed at Mayo prior to completion
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure manifested CD4 counts of less than 500 cells/microliter in the immediate (day 1) post-operative period. This study will investigate whether or not Nelfinavir increases those CD4 counts in the post-operative period.
Detailed Description
See Brief Summary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Bypass
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nelfinavir/placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nelfinavir/placebo
Intervention Description
1250mg/twice each day/four days.
Primary Outcome Measure Information:
Title
Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter
Time Frame
Six days.
Secondary Outcome Measure Information:
Title
Changes in quantitative measure of inflammatory markers
Time Frame
Six days.
Title
Changes in clinical outcomes.
Time Frame
Six days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any patient undergoing elective (non-emergency) cardiopulmonary bypass for coronary artery bypass grafting, cardiac valve replacement, or both.
Exclusion Criteria:
A dozen different medical conditions and two dozen medical contraindications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D. Badley, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor
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