The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Nitrogen Balance
研究概览
简要总结
This prospective, double-blinded study will determine the feasibility of determining the efficacy of a weekly intramuscular injection of nandrolone (an anabolic steroid) in malnourished ICU patients.The data from this study will also enable us to prepare a future grant proposal with a calculated sample size necessary to demonstrate an improvement in clinical outcome.
详细描述
Critically ill patients are particularly prone to excessive catabolism using skeletal muscle as the primary substrate as a result of maladaptation to critical illness. Ultimately, critical illness leads to a significant loss of lean body mass (LBM). For example, a 40% loss of LBM is associated with a 100% mortality. Anabolic steroids have been studied and have been shown to improve nutrition in select malnourished patient groups, however, the majority of these studies were not well designed or consisted of small sample sizes.
Our hypothesis is anabolic steroid administration will result in an augmentation of positive nitrogen balance and LBM. This increase in LBM will result in liberation from mechanical ventilation sooner than the placebo group and will result in discharge from the ICU sooner, and as a result, a reduction in morbidity (nosocomial infections) and possibly mortality.
All moderately to severly malnourished ICU patients who have an anticipated stay in ICU > 10 days, will be randomized to receive nandrolone (25 mg-females, 50 mg;males) once weekly for six weeks or placebo. All patients will receive a standard enteral nutritional regimen. Patients will be monitored for assessment of nitrogen balance, lean body mass, and length of time spent on ventilator, in ICU and in HOSP, and incidence of infections.Lean body mass will be measured using a bioimpedance analyzer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •anticipated length of stay in ICU >10 days
- •moderate to severe malnutrition
- •patient tolerating enteral feeds
排除标准
- •age < 18 yrs
- •known allergy to nandrolone
- •women of child bearing age with positive pregnancy test
- •contraindications to intramuscular injections ie anticoagulation
- •renal failure requiring renal replacement therapy
- •patients with breast or prostate cancer -
研究组 & 干预措施
nandrolone
Patients receive weekly injections of nandrolone
干预措施: Nandrolone (anabolic steroid) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Nitrogen Balance
次要结局
- Lean body mass
- serum prealbumin
- length of stay on ventilator, in ICU, in HOSPITAL
- infectious complications
- outcome (mortality)
