Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intensivmedizin SPZ, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01980784
First received: October 17, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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
Spinal Cord Injuries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • Changes in energy expenditure [ Time Frame: 2, 6, 10, 14 and 26 weeks after spinal cord injury ] [ Designated as safety issue: No ]
    Resting energy expenditure [kcal/day] measured by indirect calorimetry.


Secondary Outcome Measures:
  • Changes in body composition [ Time Frame: 2, 6, 10, 14 and 26 weeks after spinal cord injury ] [ Designated as safety issue: No ]
    Body composition measured by bioelectric impedance analysis


Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 25
Study Start Date: June 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of a spinal cord injury rehabilitation centre

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980784

Locations
Switzerland
Swiss Paraplegic Centre Nottwil
Nottwil, Lucerne, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
  More Information

No publications provided

Responsible Party: Intensivmedizin SPZ, Dr. Peter Felleiter, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01980784     History of Changes
Other Study ID Numbers: SPZ12036
Study First Received: October 17, 2013
Last Updated: February 7, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Paraplegic Centre Nottwil:
Spinal Cord Injury

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

ClinicalTrials.gov processed this record on August 26, 2014