Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor

Cardiopulmonary Bypass Clinical Trial

Official title:

Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor in the Perioperative Period

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00385450
• Other study ID #: 05-004052 00
• Status: Terminated
• Phase: Phase 1
• First received: October 5, 2006
• Last updated: April 27, 2015
• Start date: October 2006
• Est. completion date: October 2008

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

See Brief Summary.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Lymphopenia

Intervention

Drug:
• Nelfinavir/placebo
1250mg/twice each day/four days.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter		Six days.	No
Secondary	Changes in quantitative measure of inflammatory markers		Six days.	No
Secondary	Changes in clinical outcomes.		Six days.	Yes

External Links

•   Mayo Clinic Clinical Trials