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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-09-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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Graft-Versus-Host Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High risk

Patients who are at high risk of developing acute or chronic GVHD

No interventions assigned to this group

GVHD

Patients who currently have either grade II or greater acute GVHD, or clinically extensive chronic GVHD

No interventions assigned to this group

Eligibility Criteria

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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