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临床试验/NCT01980784
NCT01980784已完成不适用

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

Swiss Paraplegic Research, Nottwil1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Changes in energy expenditure

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Changes in energy expenditure

时间窗: 2, 6, 10, 14 and 26 weeks after spinal cord injury

Resting energy expenditure \[kcal/day\] measured by indirect calorimetry.

次要结局

  • Changes in body composition(2, 6, 10, 14 and 26 weeks after spinal cord injury)

研究者

发起方
Swiss Paraplegic Research, Nottwil
申办方类型
Network
责任方
Principal Investigator
主要研究者

Intensivmedizin SPZ

Dr. Peter Felleiter

Swiss Paraplegic Research, Nottwil

研究点 (1)

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