Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT01980784|
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : November 28, 2016
Severe trauma induces massive metabolic changes that are characterized by hypermetabolism with increased energy expenditure and catabolism. Early enteral and, if necessary, parenteral feeding is a major focus of modern intensive care medicine.
After acute spinal cord injury, denervation of skeletal muscle leads to a massive loss of muscle mass in the area below the level of injury. This dramatic muscle atrophy again leads to a decrease in energy expenditure. Whereas other survivors of severe trauma typically regain muscle mass during rehabilitation, spinal cord injury patients typically continue to lose muscle mass over time, which also leads to changes in body composition. The time course of these changes is not known. Continuing nutrition without adaption to the reduced energy expenditure leads to weight gain and adiposity, exposing many chronic spinal cord injury patients to the known unfavorable metabolic consequences. Knowledge of the time course of these changes would help to provide adequate caloric intake to the patients and improve our ability for nutrition counseling.
The investigators plan a prospective clinical trial in 25 acute spinal cord injury patients to determine the changes in energy expenditure and body composition. Major inclusion criteria are acute traumatic spinal cord injury, age 18-70, neurological level above L1, AIS (American Spinal Injury Association Impairment Scale) A, B or C.
Measurements of energy expenditure, body composition and nutritional markers in venous blood are scheduled 2, 6, 10 and 14 weeks after spinal cord injury and at the end of rehabilitation (at the latest after 26 weeks).
|Condition or disease|
|Spinal Cord Injuries|
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
- Changes in energy expenditure [ Time Frame: 2, 6, 10, 14 and 26 weeks after spinal cord injury ]Resting energy expenditure [kcal/day] measured by indirect calorimetry.
- Changes in body composition [ Time Frame: 2, 6, 10, 14 and 26 weeks after spinal cord injury ]Body composition measured by bioelectric impedance analysis
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980784
|Swiss Paraplegic Centre Nottwil|
|Nottwil, Lucerne, Switzerland, 6207|