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

Ann & Robert H Lurie Children's Hospital of Chicago logo

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Completed

Conditions

Graft-Versus-Host Disease

Study type

Observational

Funder types

Other

Identifiers

NCT00600314
SCT 0405 REE

Details and patient eligibility

About

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.

Full 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).

Enrollment

20 patients

Sex

All

Ages

7 to 30 years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

High risk
Description:
Patients who are at high risk of developing acute or chronic GVHD
GVHD
Description:
Patients who currently have either grade II or greater acute GVHD, or clinically extensive chronic GVHD

Trial contacts and locations

1

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Central trial contact

Meredith Marshall; Morris Kletzel, MD

Data sourced from clinicaltrials.gov

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