Macrophage Inhibitory Factor and High-Mobility Group-1 Protein in Children Undergoing Cardiopulmonary Bypass

NCT00692432 | Completed

• 1 other identifier: 0901-475
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Myocardial Depression

Keywords

Macrophage Migration Inhibitory Factor; MIF; Cardiopulmonary bypass; CPB; inflammation; inflammatory marker; myocardial depression; myocardial depressant factor

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours

Secondary Outcomes (2)

• MIF levels in human serum and myocardial cells will correlate with clinical outcome following CPB.

  72 hours

• Presence or absence of HMG-1 in the serum of patients undergoing CPB will correlate with clinical outcome.

  72 hours

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children at Children's Medical Center Dallas who are having cardiac surgery that requires CPB and an expectation of cardiac tissue removal.

You may qualify if:

• Any child under the age of 5 undergoing operative repair of congenital heart disease on CPB where there is an expectation of cardiac tissue removal.
• Written informed consent obtained from a parent/legal guardian.

You may not qualify if:

• Unable to obtain informed consent
• Evidence of ongoing infection
• Known immunodeficiency

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Children's Medical Center Dallas: collaborator

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cardiac tissue serum

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leslie Garner, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: September 1, 2001
• Primary Completion: September 1, 2003
• Study Completion: December 1, 2008
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)