Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation

NCT ID: NCT04535570

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-03-31

Brief Summary

The treatment before bone marrow transplantantion is initiated by chemotherapy associated or not with radiotherapy, both of which cause various side effects on the patient as symptoms that impair food intake. The nutritional status of the patient is one of the factors related to the success of the transplant, so a complete nutritional assessment before transplantation is necessary in order to identify patients at nutritional risk, nutritional disorders and to perform appropriate and early intervention to promote recovery and / or health maintenance. Will be used for nutritional assessment: arm perimeter, arm muscle area; electrical bioimpedance, phase angle, and Indirect Calorimetry, a standard method of noninvasive nutritional assessment that expresses the nutritional demand and rate of utilization of energy substrates from oxygen consumption and carbon dioxide production through the air inhaled and exhaled by the individual's lungs.

Conditions

Bone Marrow Transplantation; Hematopoietic Stem Cell Transplantation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre Transplant

All 20 patients will have the energy expenditure measured in the pre-transplantation in order to compare with post-transplant data.

Indirect Calorimetry

Intervention Type: OTHER

In the pre-transplant, before the conditioning regime, and also on the 10th and 17th post-transplant, the resting energy expenditure was measured by indirect calorimetry.

Post Transplant

All 20 patients will have the energy expenditure measured in the post transplantation in order to compare with the pre-transplant data.

Indirect Calorimetry

Intervention Type: OTHER

In the pre-transplant, before the conditioning regime, and also on the 10th and 17th post-transplant, the resting energy expenditure was measured by indirect calorimetry.

Interventions

Indirect Calorimetry

In the pre-transplant, before the conditioning regime, and also on the 10th and 17th post-transplant, the resting energy expenditure was measured by indirect calorimetry.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with hematological disease
• Age equal or superior to 15 years old
• Both sexes
• Will be submitted bone marrow transplantation

Exclusion Criteria

• Age below 15 years old
• Those who can't perform calorimetry (oxygen therapy, mechanical ventilation)
• Have hyper or hypothyroidism
• Admitted to the Intensive Care Unit (without at least one result of post-transplant indirect calorimetry)
• Don't agree to participate in the study

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Maria Isabel Toulson Davisson Correia

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone V Generoso

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Escola de Enfermagem - UFMG

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

58010016.0.0000.5149

Identifier Type: -

Identifier Source: org_study_id