NCT01536275进行中（未招募）不适用
Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- KU Leuven
- 入组人数
- 1,440
- 试验地点
- 3
- 主要终点
- Incidence of new infection during ICU stay
研究概览
简要总结
In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the PICU with a STRONGkids score of 2 points or more upon ICU admission
排除标准
- •Age of 17 years or older
- •Patients with a DNR code at the time of ICU admission.
- •Patients expected to die within 12 hours (=moribund patients).
- •Patient readmitted to ICU after randomization to the PEPaNIC trial, more than 48 hours after the initial discharge
- •Patients transferred from another paediatric intensive care after a stay of more than 7 days
- •Patients suffering from ketoacidotic or hyperosmolar coma on admission.
- •Patients suffering from Short Bowel Syndrome on home PN or other conditions that require home PN
- •Patients suspicious or established inborn metabolic diseases requiring specific diet
- •STRONGkids score lower than 2 on ICU admission.
- •Premature Newborns ( 37 weeks gestational age upon admission in the PICU)
- •Prior inclusion in another randomized controlled outcome study
研究组 & 干预措施
Early parenteral nutrition
No Intervention
Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center
Late parenteral nutrition
Experimental
Parenteral nutrition will be withheld during the first 7 days of ICU stay
干预措施: Late parenteral nutrition (Other)
结局指标
主要结局
Incidence of new infection during ICU stay
时间窗: during ICU stay and up to 90 days post-randomization
Duration of ICU dependency (crude stay days and time to alive discharge from ICU)
时间窗: during ICU stay and up to 90 days post-randomization
次要结局
- Incidence of liver dysfunction during ICU stay(during ICU stay and up 90 days post-randomization)
- Need for haemodynamic support during ICU stay(during ICU stay and up 90 days post-randomization)
- Incidence of new kidney injury during ICU stay(during ICU stay and up 90 days post-randomization)
- Number of readmissions to the ICU(up to 90 days post-randomization)
- health economy analysis(during index hospitalization)
- Mortality(during ICU stay, hospital stay and up to 90 days post-randomization)
- Incidence of hypoglycaemia during ICU stay(during the intervention window up to day 8 post-randomization)
- Time to alive discharge from hospital(during hospital stay and up to 90 days post-randomization)
- Time to final weaning from mechanical respiratory support(during ICU stay and up to 90 days post-randomization)
- Duration of antibiotics treatment during ICU stay(during ICU stay and up to 90 days post-randomization)
- Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance(during the intervention window of 8 days and up to 90 days post-randomization)
- Structural and or functional differences in muscle tissue during ICU stay(during ICU stay and up to 90 days post-randomization)
- biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples(up to 4 years post-randomization)
- functional and neurocognitive development(up to 4 years post-randomization)
- Markers of inflammation such as C-reactive protein concentrations during ICU stay(during ICU stay and up to 90 days post-randomization)
研究者
Greet Van den Berghe
Head of Dept Intensive Care Medicine
KU Leuven
研究点 (3)
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