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Completed

NCT Number: NCT00600314

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.

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Key information

Conditions

Graft-Versus-Host Disease Graft vs Host Disease Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

7 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Memorial Hospital

Chicago, Illinois, 60614-3363, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Spring of 2010

Secondary outcomes

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

    Time frame: Spring of 2012

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jan 24, 2008
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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