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

NCT01980784 | Completed

• 1 other identifier: 2012-08
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Changes in energy expenditure

  Resting energy expenditure \[kcal/day\] measured by indirect calorimetry.

  2, 6, 10, 14 and 26 weeks after spinal cord injury

Secondary Outcomes (1)

• Changes in body composition

  2, 6, 10, 14 and 26 weeks after spinal cord injury

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of a spinal cord injury rehabilitation centre

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Peter Felleiter

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: November 11, 2013
• Study Start: June 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

CH (1)