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NCT00692432 · ClinicalTrials.gov registry record
Macrophage Inhibitory Factor and High-Mobility Group-1 Protein in Children Undergoing Cardiopulmonary Bypass
A clinical trial of Myocardial Depression, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT00692432 is a study of Myocardial Depression that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00692432, a study of Myocardial Depression, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Study Locations (1)
Texas
- Children's Medical Center Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-09 |
| Est. Completion | 2008-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00692432
The ClinicalTrials.gov registry entry for NCT00692432 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myocardial Depression appearing as the primary indexed condition, and to 0 interventions.
NCT00692432 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00692432 about?
NCT00692432 is a clinical study titled "Macrophage Inhibitory Factor and High-Mobility Group-1 Protein in Children Undergoing Cardiopulmonary Bypass". 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 ca...
What is the current status of trial NCT00692432?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2001-09. Estimated completion is 2008-12.
What conditions does trial NCT00692432 study?
This clinical trial studies the following conditions: Myocardial Depression.
Who is sponsoring clinical trial NCT00692432?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00692432 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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