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OpenTrials
Completed

NCT Number: NCT01980784

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2013
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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