Macrophage Inhibitory Factor (MIF) and High-Mobility Group-1 Protein (HMG-1) in Children Undergoing Cardiopulmonary Bypass
Recruitment status was Active, not recruiting
Introduction: In recent scientific literature, 2 proteins, macrophage migration inhibitory factor (MIF) and high-mobility group-1 protein (HMG-1), have emerged as important mediators of inflammation and sepsis.
Hypothesis: MIF and HMG-1 will be present in the serum of children who have undergone cardiopulmonary bypass. MIF will be present in the myocardium of children who have undergone cardiopulmonary bypass. The presence of MIF and HMG-1 in the serum and MIF in the myocardium of children undergoing bypass will correlate with clinical outcome.
Methods: We will study a group of infants and children undergoing operative repair of congenital heart disease during which there is an expectation of cardiac tissue removal. Patients will have an assessment of cardiac function by echocardiography as well as blood assays for tumor necrosis factor (TNF), interleukin-6, interleukin-8, interleukin-10, MIF, and HMG-1 prior to surgery. Cardiac tissue, removed as a planned part of the procedure, will be obtained from the cardiothoracic surgeons and assayed for MIF and for apoptosis, a potential mechanism of myocardial dysfunction mediated by MIF and/or HMG-1. The patient will be admitted to the cardiac intensive care unit post operatively for routine care. Blood will be obtained at 1, 8, 24, 28, and 72 hours post operatively for the cytokine assays detailed above. The blood will be drawn from indwelling arterial or venous catheters routinely placed at the time of surgery. The amount of blood drawn (-4cc per sample) is unlikely to cause any hemodynamic compromise or result in additional blood product replacement.
Sample size and Analysis Plan: 30 subjects will be enrolled to determine the presence or absence of MIF/HMG-1 in the serum and cardiac tissue pre and post cardiopulmonary bypass. Descriptive statistics of patient demographics and clinical outcome variables will be correlated to serum and myocardial concentrations of the various cytokines.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Macrophage Inhibitory Factor (MIF) and High-Mobility Group-1 Protein (HMG-1) in Children Undergoing Cardiopulmonary Bypass|
- MIF and HMG-1 will be present in the serum of children who have undergone cardiopulmonary bypass. MIF will be present in the myocardium of children who have undergone cardiopulmonary bypass. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- MIF levels in human serum and myocardial cells will correlate with clinical outcome following CPB. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- Presence or absence of HMG-1 in the serum of patients undergoing CPB will correlate with clinical outcome. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
cardiac tissue serum
|Study Start Date:||September 2001|
|Estimated Study Completion Date:||December 2008|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692432
|United States, Texas|
|Children's Medical Center Dallas|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Leslie Garner, MD||UT Southwestern|