Pilot Study of Low-Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Length of stay (LOS) in the ICU.
研究概览
简要总结
This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in patients with bacterial septic shock.
详细描述
This study seeks to assess the tolerability of utilizing low-carbohydrate nutrition in patients admitted to the MICU with bacterial septic shock. Low carbohydrate feeds have been used before in the critical care setting and were well-tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 admitted to the MICU with a diagnosis of severe sepsis or septic shock
- •Patients with 35 > BMI > 18.5
- •Patients with serum pro-calcitonin > 1 ng/mL in the first 24 hours of hospitalization
排除标准
- •Patients with chronic kidney disease as defined by glomerular filtration rate < 60 for > 6 months
- •Patients with chronic liver disease as defined by radiographic or tissue evidence of cirrhosis or persistently abnormal liver function tests for > 6 months
- •Patients with current malignancies
- •Patients with autoimmune disease on current immunotherapy
- •Patients on corticosteroids at doses of prednisone or prednisone-equivalents > 5 mg for > 6 months
- •Patients with weight-reduction surgeries
- •Patients with positive viral studies in the first 24 hours of admission
研究组 & 干预措施
low carbohydrate nutrition
We will use a low-carbohydrate nutrition (LCN) formulated by the MICU registered dietitian and pharmacy staff, who routinely prepare enteral and parenteral nutrition which will provide:
5% carb, 41% protein, 54% lipid.
干预措施: low-carbohydrate nutrition (Dietary Supplement)
standard enteral nutrition
The standard enteral nutrition (SEN) and per cent contribution of carbohydrates used in the Yale MICU is as follows:
Jevity 1.2 56% carb, 29.5% lipid, 18.5% protein Diabetisource 33% carb, 44% lipid, 20% protein Promote 55% carb, 25% lipid, 25% protein Vital AF 37% carb, 40% lipid, 25% protein Peptamin Intense 29% carb, 34% lipid, 37% protein Osmolite 1.5 54% carb, 29.5% lipid, 16.5% protein
干预措施: Standard enteral nutrition (Dietary Supplement)
结局指标
主要结局
Length of stay (LOS) in the ICU.
时间窗: discharge: average 5 days.
The primary clinical outcome will be to reduce the length of stay (LOS) in the ICU. Average length of stay is 5 days.
次要结局
未报告次要终点