The Effect of Standard or Higher Protein Feeding on Indicator Amino Acid Oxidation in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Indicator amino acid oxidation
研究概览
简要总结
This study will use the indicator amino acid oxidation technique (IAAO) to determine protein oxidation of ICU patients at two protein intakes: 1.3 g/kg/d versus 2.0 g/kg/d.
详细描述
Rationale:
While protein administration guidelines for critical care are available from international organizations such as ASPEN and ESPEN, they vary greatly in their recommended dose and are based on relatively low-quality evidence. The Indicator Amino Acid Oxidation (IAAO) technique has been developed as a more practical and non-invasive tool to assess protein metabolism that can be used in vulnerable populations. Application of the IAAO technique in patients admitted to the Intensive Care Unit (ICU) could provide an alternative to better investigate optimal protein feeding during critical illness.
Objective:
To assess the effect of enteral feeding with higher protein content compared to standard protein content on indicator amino acid oxidation in ICU patients.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Unplanned admission to the ICU
- •Mechanically ventilated
- •Start of enteral nutrition within 2 days of intubation
- •≥ 3 days on enteral nutrition
- •Expected remaining ICU stay on mechanical ventilation of ≥ 2 days
排除标准
- •Contra-indication for enteral nutrition at the discretion of the treating physician
- •Feeding intolerance during incremental feeding protocol
- •Moribund or withholding of treatment
- •On extracorporeal membrane oxygenation (ECMO)
- •Presence of chest drains, pneumothorax, tracheoesophageal fistula or subcutaneous emphysema
- •Kidney failure AND a "no dialysis"-code on admission
- •Hepatic encephalopathy (West Haven criteria 3-4)
- •BMI < 18 kg/m2
研究组 & 干预措施
1.3 g/kg/day followed by 2.0 g/kg/day
Patients in this arm will, on their first test day, receive enteral nutrition containing 1.3 grams of protein per kg of body weight per day followed by 2.0 grams of protein per kg of body weight per day on their second test day.
干预措施: Standard protein enteral nutrition with enteral tracer (Combination Product)
1.3 g/kg/day followed by 2.0 g/kg/day
Patients in this arm will, on their first test day, receive enteral nutrition containing 1.3 grams of protein per kg of body weight per day followed by 2.0 grams of protein per kg of body weight per day on their second test day.
干预措施: High protein enteral nutrition with enteral tracer (Combination Product)
2.0 g/kg/day followed by 1.3 g/kg/day
Patients in this arm will, on their first test day, receive enteral nutrition containing 2.0 grams of protein per kg of body weight per day followed by 1.3 grams of protein per kg of body weight per day on their second test day.
干预措施: Standard protein enteral nutrition with enteral tracer (Combination Product)
2.0 g/kg/day followed by 1.3 g/kg/day
Patients in this arm will, on their first test day, receive enteral nutrition containing 2.0 grams of protein per kg of body weight per day followed by 1.3 grams of protein per kg of body weight per day on their second test day.
干预措施: High protein enteral nutrition with enteral tracer (Combination Product)
结局指标
主要结局
Indicator amino acid oxidation
时间窗: Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission.
Indicator amino acid oxidation expressed as µmol/kg/h
次要结局
- 13CO2 excretion in breath (F13CO2)(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- Enrichments of urine L-[1-13C]-phenylalanine(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- Concentration of plasma phenylalanine(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- Enrichments of plasma L-[1-13C]-phenylalanine(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- Fecal output and fecal protein content(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected from start of intervention until end of intervention & tracer protocol.)
- Enrichment of breath 13CO2(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- CO2 production(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected 2 hours after start of tracer protocol.)