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

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.

Study Overview

• Status: Completed
• Conditions: Graft-Versus-Host Disease

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60614-3363
      • Children's Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 30 years (Child, Adult)
• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility - can the procedure be adequately performed in a child?	Spring of 2010

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Morris Kletzel, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: January 8, 2008
• First Submitted That Met QC Criteria: January 11, 2008
• First Posted (Estimated): January 24, 2008

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Graft-Versus-Host Disease; Transplantation, Allogeneic; Transplantation, Hematopoietic Stem Cell; Calorimetry, Respiration
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: SCT 0405 REE