Spinal Cord InjuriesNCT01980784
Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of a spinal cord injury rehabilitation centre
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre Nottwil
Nottwil, Canton of Lucerne, 6207
About this study
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.
Read more
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
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in energy expenditure
Resting energy expenditure [kcal/day] measured by indirect calorimetry.
Measured: 2, 6, 10, 14 and 26 weeks after spinal cord injury
Secondary outcomes (1)
Changes in body composition
Body composition measured by bioelectric impedance analysis
Measured: 2, 6, 10, 14 and 26 weeks after spinal cord injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJun 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Intensivmedizin SPZ, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980784
- Sponsor's protocol ID
- 2012-08
- Status last verified
- Nov 2016
- First submitted
- 17 Oct 2013
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01980784
- Acronym / sponsor ID
- 2012-08
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of a spinal cord injury rehabilitation centre
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Changes in body composition
Time frame: 2, 6, 10, 14 and 26 weeks after spinal cord injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in energy expenditure (time frame: 2, 6, 10, 14 and 26 weeks after spinal cord injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.