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

NCT00600314 | Completed

• 1 other identifier: SCT 0405 REE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft-Versus-Host Disease

Keywords

Graft-Versus-Host Disease; Transplantation, Allogeneic; Transplantation, Hematopoietic Stem Cell; Calorimetry, Respiration

Outcome Measures

Primary Outcomes (1)

• Feasibility - can the procedure be adequately performed in a child?

  Spring of 2010

Secondary Outcomes (1)

• Measure of resting energy expenditure - kcal/day and oxygen consumption (VO2 mL/min)

  Spring of 2012

Study Arms (2)

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

Eligibility Criteria

• Age: 7 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Inability to meet the requirements of the study procedures
• Any subject who is receiving supplemental oxygen
• Withdrawal of consent

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Children's Memorial Hospital

Chicago, Illinois, 60614-3363, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Morris Kletzel, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 24, 2008
• Study Start: April 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (1)