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

Mayo Clinic

Status and phase: Terminated; Phase 1

Conditions: Cardiopulmonary Bypass

Treatments: Drug: Nelfinavir/placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00385450

05-004052 00

Details and patient eligibility

About

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.

Full description

See Brief Summary.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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41 participants in 1 patient group

Nelfinavir/placebo

Experimental group

Treatment:

Drug: Nelfinavir/placebo