Impact of Supplemental Parenteral Nutrition (SPN) on Energy Balance, and Infection Rate in Intensive Care Patients: Underlying Metabolic, Inflammatory and Immune Mechanisms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Glucose and Leucine turnover
研究概览
简要总结
Having previously demonstrated that supplemental parenteral nutrition to complete an insufficient enteral nutrition (EN) between D4 and D8 improves outcome after critical illness, by reducing infectious complications, the present trial aims at investigating the underlying carbohydrate and protein metabolism changes, as well as the immune and inflammatory modulations associated with this improvement.
详细描述
Enrollment on day 3 of critically ill patients, without contraindication to EN, not achieving 60% of the ICU per protocol energy target.
Intervention: Randomization to either continued pure EN, or from day 4 to supplemental PN to complete EN at target validated by indirect calorimetry.
Measurements: Indirect calorimetry on Days 3, 4, 9 (twice). Primary endpoints = glucose and leucine metabolism On days 4 and 9-10: isotopic investigation of glucose metabolism, and immune and inflammatory responses// Day 9-10: isotopic investigation of protein (leucine) metabolism Secondary endpoints: Insulin requirements, area under the curve (AUC) of blood Glucose, infections after day 9, overall complications, length of mechanical ventilation, of ICU and hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •estimated duration of ICU stay > 5 days,
- •estimated survival > 7 days,
- •absence of contraindication to EN
- •need for mechanical ventilation
- •informed consent obtained from patients, close relative, or referring physician
排除标准
- •refusal of the patient or of the next of kin
- •age < 18 years
- •non-functional digestive tract (short bowel, persistent ileus, proximal intestinal fistula high rate > 1.5 litres/day)
- •already receiving PN before Day 3
- •absence of a central venous catheter
- •women who are pregnant (pregnancy test).
- •Admission after cardiac arrest, or severe brain injury
结局指标
主要结局
Glucose and Leucine turnover
时间窗: 10 days
On D04:Infusion after priming of 6.6 2H2 glucose and NaH13CO3 On Day 09-10: Infusion after priming of NaH13CO3 and of L-\[1-13C\]-Leucine + repeat of the glucose sequence
次要结局
- Immune and inflammatory impact of optimized target feeding(10 days)
研究者
Mette M Berger
Prof
Centre Hospitalier Universitaire Vaudois