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

Graft-Versus-Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00600314
• Other study ID #: SCT 0405 REE
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2008
• Last updated: October 7, 2010
• Start date: April 2005
• Est. completion date: April 2012

Study information

• Verified date: October 2010
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Morris Kletzel, MD
• Phone: 773-880-4562
• Email: MKletzel[@]childrensmemorial.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 30 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease

Locations

Country	Name	City	State
United States	Children's Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - can the procedure be adequately performed in a child?		Spring of 2012	No
Secondary	Measure of resting energy expenditure - kcal/day and oxygen consumption (VO2 mL/min)		Spring of 2012	No