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).
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Lucerne
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Nottwil、Lucerne、スイス、6207
- Swiss Paraplegic Centre Nottwil
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in energy expenditure
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in body composition
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
脊髄損傷の臨床試験
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Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud Centre, Lisbon,...積極的、募集していないメラノーマ | 肉腫 | 卵巣がん | 骨 | 軟部組織 | リンパ節 | CNS-Spinal CD/MEMBR、NOSアメリカ, イタリア, ポルトガル