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

Completed

• Conditions: Graft-Versus-Host Disease

• Registration Number: NCT00600314
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

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.

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).

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-24
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility - can the procedure be adequately performed in a child?	Spring of 2010

Secondary Outcome Measures

Name	Time	Method
Measure of resting energy expenditure - kcal/day and oxygen consumption (VO2 mL/min)	Spring of 2012

Trial Locations

Locations (1)

Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States