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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Intensivmedizin SPZ

Dr. Peter Felleiter

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-08

Identifier Type: -

Identifier Source: org_study_id