Clinical Trial: Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor in the Perioperative Period
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 Summary: See Brief Summary.
Sponsor: Mayo Clinic
Current Primary Outcome: Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter [ Time Frame: Six days. ]
Original Primary Outcome: Proportion of Nelfinavir patients v. porportion of placebo patients who have CD4 counts of less than 500 cells/microliter
Current Secondary Outcome:
- Changes in quantitative measure of inflammatory markers [ Time Frame: Six days. ]
- Changes in clinical outcomes. [ Time Frame: Six days. ]
Original Secondary Outcome:
- Changes if CD4 and CD8 T-cell lymphocyte apoptosis between groups
- Changes in quantitative measure of inflammatory markers
- Changes in clinical outcomes
Information By: Mayo Clinic
Dates:
Date Received: October 5, 2006
Date Started: October 2006
Date Completion:
Last Updated: April 27, 2015
Last Verified: April 2015
