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Measurements of Resting Energy Expenditure in Patients With or at Risk of Developing Graft Versus Host Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600314
First Posted: January 24, 2008
Last Update Posted: October 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
  Purpose
This study aims to show that the MedGem indirect calorimetry measurement device will be feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD will have elevated REE that is not adequately predicted by standard equations.

Condition
Graft-Versus-Host Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurements of Resting Energy Expenditure in Patients With or at Risk of Developing Graft Versus Host Disease

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Feasibility - can the procedure be adequately performed in a child? [ Time Frame: Spring of 2012 ]

Secondary Outcome Measures:
  • Measure of resting energy expenditure - kcal/day and oxygen consumption (VO2 mL/min) [ Time Frame: Spring of 2012 ]

Estimated Enrollment: 60
Study Start Date: April 2005
Estimated Study Completion Date: April 2012
Groups/Cohorts
High risk
Patients who are at high risk of developing acute or chronic GVHD
GVHD
Patients who currently have either grade II or greater acute GVHD, or clinically extensive chronic GVHD

Detailed Description:
Chronic Graft versus Host Disease (GVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow and hematopoietic progenitor cell transplantation. In adults, it has been shown that patients with acute or chronic GVHD have an increase in their resting energy expenditure (REE), likely as a result of chronic systemic inflammation. These studies have not yet been performed in children. This study's objective is to determine the REE of pediatric patients with acute and chronic GVHD after hematopoietic stem cell transplantation (HSCT).
  Eligibility

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Ages Eligible for Study:   7 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

High risk population: patients who are at high risk of developing acute or chronic Graft versus Host Disease (GVHD) following an allogeneic transplant.

GVHD population: patients with active GHVD, either acute or chronic

Criteria

Inclusion Criteria:

  • Subjects must be 7-30 years of age
  • Signed informed consent
  • One of the following three criteria must be met:

    • Presence of grade II or greater acute GVHD as defined by Keystone criteria
    • Presence of clinically extensive chronic GVHD as defined by the revised Seattle criteria
    • Any subject identified prior to allogeneic transplant, or following allogeneic transplant, who is at risk for acute or chronic GVHD

Exclusion Criteria:

  • Inability to meet the requirements of the study procedures
  • Any subject who is receiving supplemental oxygen
  • Withdrawal of consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600314


Contacts
Contact: Morris Kletzel, MD 773-880-4562 MKletzel@childrensmemorial.org
Contact: Meredith Marshall 773-880-3459 MEMarshall@childrensmemorial.org

Locations
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614-3363
Principal Investigator: Morris Kletzel, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Morris Kletzel, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Responsible Party: Morris Kletzel, MD, Children' Memorial Hospital
ClinicalTrials.gov Identifier: NCT00600314     History of Changes
Other Study ID Numbers: SCT 0405 REE
First Submitted: January 8, 2008
First Posted: January 24, 2008
Last Update Posted: October 11, 2010
Last Verified: October 2010

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Graft-Versus-Host Disease
Transplantation, Allogeneic
Transplantation, Hematopoietic Stem Cell
Calorimetry, Respiration

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases