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 because the information has not been verified recently.
Verified October 2010 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00600314
First received: January 8, 2008
Last updated: October 7, 2010
Last verified: October 2010
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure of resting energy expenditure - kcal/day and oxygen consumption (VO2 mL/min) [ Time Frame: Spring of 2012 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   7 Years to 30 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Morris Kletzel, MD, Children' Memorial Hospital
ClinicalTrials.gov Identifier: NCT00600314     History of Changes
Other Study ID Numbers: SCT 0405 REE
Study First Received: January 8, 2008
Last Updated: October 7, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014