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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
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Design

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury
Study Start Date : June 2012
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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
whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of a spinal cord injury rehabilitation centre

Inclusion Criteria:

  • patients admitted for acute treatment and rehabilitation after traumatic spinal cord injury
  • no longer then two weeks after onset of spinal cord injury
  • age 18 - 70 years
  • body mass index 18-30
  • neurological level C4 to Th12
  • American Spinal Injury Association Impairment Scale (AIS) A, B or C

Exclusion Criteria:

  • complications during acute treatment, which make study participation impossible or would endanger the recovery of the patient
  • pre-existing diabetes mellitus type 1 and 2
  • pre-existing hypercholesterolemia
  • untreated hypothyroidism or hyperthyroidism
  • invasive mechanical ventilation
  • cardiac pacemaker
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
More Information

Responsible Party: Intensivmedizin SPZ, Dr. Peter Felleiter, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01980784     History of Changes
Other Study ID Numbers: 2012-08
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

Keywords provided by Intensivmedizin SPZ, Swiss Paraplegic Centre Nottwil:
Spinal Cord Injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System