This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
Children's Medical Center Dallas
Information provided by (Responsible Party):
Leslie Garner, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00692432
First received: June 4, 2008
Last updated: May 9, 2017
Last verified: May 2017
  Purpose

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.


Condition
Myocardial Depression

Study Type: Observational
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

Further study details as provided by Leslie Garner, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • MIF levels in human serum and myocardial cells will correlate with clinical outcome following CPB. [ Time Frame: 72 hours ]
  • Presence or absence of HMG-1 in the serum of patients undergoing CPB will correlate with clinical outcome. [ Time Frame: 72 hours ]

Biospecimen Retention:   Samples Without DNA
cardiac tissue serum

Enrollment: 30
Study Start Date: September 2001
Study Completion Date: December 2008
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. 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.
  2. Written informed consent obtained from a parent/legal guardian.

Exclusion Criteria:

  1. Unable to obtain informed consent
  2. Evidence of ongoing infection
  3. Known immunodeficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692432

Locations
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Children's Medical Center Dallas
Investigators
Principal Investigator: Leslie Garner, MD UT Southwestern
  More Information

Responsible Party: Leslie Garner, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00692432     History of Changes
Other Study ID Numbers: 0901-475
Study First Received: June 4, 2008
Last Updated: May 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Leslie Garner, University of Texas Southwestern Medical Center:
Macrophage Migration Inhibitory Factor
MIF
Cardiopulmonary bypass
CPB
inflammation
inflammatory marker
myocardial depression
myocardial depressant factor

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 19, 2017