NCT01274650

Brief Summary

Patient nutritional needs vary depending on several factors including age, sex, height, weight, injury and co-morbidities. Since injury affects energy expenditure in patients, this must be taken into account when assessing nutritional requirements. Indirect calorimetry will be used to measure energy expenditure of patients with decubitus ulcers of varying degrees. The primary objective of this study is to determine the effects of wound volume on metabolic rate and compare this to predictive equations used for estimating energy requirements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

January 4, 2011

Last Update Submit

October 12, 2016

Conditions

Decubitis Ulcer

Outcome Measures

Primary Outcomes (1)

  • Does the volume of decubitus ulcers have an effect on a patient's resting energy expenditure

    Data obtained in this study will be analyzed using methods that enable a description of the patient population and a comparison of the results against previously formulated equations for energy expenditure. Descriptive summaries will be presented for demographic and clinical background variables, study objectives, and outcome variables and safety endpoint

    1 year

Study Arms (1)

Decubitis Ulcer

OTHER

Patients admitted to the hospital with decubitus ulcers in the ischial, sacral, or coccyx area.

Procedure: Indirect Calorimetry

Interventions

Indirect CalorimetryPROCEDURE

Indirect Calorimetry

Also known as: Patients admitted to the hospital with decubitus ulcers in the ischial, sacral, or coccyx area
Decubitis Ulcer

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to the Saint Elizabeth Regional Burn and Wound Center
  • Ulcer located in the Ischial, Sacral, Coccyx

You may not qualify if:

  • Patient Has Signs of Infection
  • Patient is receiving oxandrolone treatment or anabolic hormone treatment
  • Is Patients receiving intermittent tube feedings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Elizabeth Regional Burn and Wound Center

Lincoln, Nebraska, 68510, United States

Location

MeSH Terms

Interventions

Calorimetry, Indirect

Intervention Hierarchy (Ancestors)

CalorimetryChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 11, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

US(1)