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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980784
• Other study ID #: 2012-08
• Status: Completed
• Phase: N/A
• First received: October 17, 2013
• Last updated: November 24, 2016
• Start date: June 2012
• Est. completion date: February 2014

Study information

• Verified date: November 2016
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre Nottwil	Nottwil	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in energy expenditure	Resting energy expenditure [kcal/day] measured by indirect calorimetry.	2, 6, 10, 14 and 26 weeks after spinal cord injury	No
Secondary	Changes in body composition	Body composition measured by bioelectric impedance analysis	2, 6, 10, 14 and 26 weeks after spinal cord injury	No