NL-OMON28381尚未招募不适用
The impact of high versus standard enteral protein provision on PGE2 levels, autophagy flux and mitochondrial function following Intensive Care admission: combined sub-studies of the PRECISe trial.
Ziekenhuis Gelderse Vallei, Wageningen University, Karolinska Institute0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •In order to be eligible to participate in the PRECISe study, a potential subject must meet all of the following criteria:
- •1.Adult = 18 years-old admitted to the ICU
- •2.Unplanned ICU admission
- •3.Invasive mechanical ventilation initiated <24 hours of ICU admission
- •4.Expected ICU stay on ventilator support of = 3 days
- •There are no additional inclusion criteria for this substudy.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in the PRECISe study:
- •1.Contraindication for enteral nutrition
- •2.Moribund or expected withholding of treatment
- •3.Kidney failure with no dialysis”-code on admission
- •4.Hepatic encephalopathy
- •5.Body-mass index <18 kg/m²
- •Additional exclusion criteria for this set of sub-studies:
- •1.Current NSAID use
- •2.Use of chronic corticosteroid or other immunosuppressive medication prior to current hospital admission.
- •3.Current use of fish oil supplements
- •4.Haemoglobin level lower than 5,5 mmol/lL
- •5.Patients referred from another ICU
- •6.Active autoimmune disease involving the lung, heart, liver, small or large intestine, or neuromuscular system (e.g., myasthenia gravis, multiple sclerosis) AND currently requiring systemic immunosuppressive therapy
- •7.Patients who experienced a significant medical or surgical event prior to current hospital admission leading to hospitalization within the previous 6 months
- •8.A disease process (e.g., end-stage cancer) with a projected survival of less than 6 months (pre-ICU admission)
- •9.Received treatment with chemotherapy, immunotherapy or radiotherapy within the past 12 months
- •10.Family history of mitochondrial disease(s) or genetic autophagy diseases.
- •11.COPD Gold-Stadium III or IV or other severe respiratory disorders (FEV1 <30% and FEV1/FVC < 0.7) (pre-ICU admission) (15)
- •12.Any stage of chronic or acute renal failure (pre-ICU admission, pre-existent SOFA 0 for this SOFA element)
- •13.Any stage of chronic or acute liver failure (pre-ICU admission, pre-existent SOFA 0 for this SOFA element)
- •14.Patients supported with haemodialysis or continuous hemofiltration
- •15.Diabetes Mellitus type I and II (pre ICU-admission)
- •16.Patients not able to understand the Dutch language
- •17.Treated with any investigational agent within 12 months prior to study treatment administration.
- •18.Patients who are = 6 months postpartum pregnancy testing to the discretion of the attending physician
- •19.(History of) drug abuse
研究者
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