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).
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Lucerne
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Nottwil, Lucerne, 스위스, 6207
- Swiss Paraplegic Centre Nottwil
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in energy expenditure
기간: 2, 6, 10, 14 and 26 weeks after spinal cord injury
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Resting energy expenditure [kcal/day] measured by indirect calorimetry.
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2, 6, 10, 14 and 26 weeks after spinal cord injury
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in body composition
기간: 2, 6, 10, 14 and 26 weeks after spinal cord injury
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Body composition measured by bioelectric impedance analysis
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2, 6, 10, 14 and 26 weeks after spinal cord injury
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
척수 손상에 대한 임상 시험
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Blayne WelkLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St....모병Spina Bifida 또는 Spinal Dysraphism캐나다
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Rennes University Hospital완전한