Early Metabolomic Support Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Nitrogen balance and Catabolic Index
研究概览
简要总结
A randomized, parallel-group, pilot study comparing the effect of the early addition of intravenous protein to enteral feeding as tolerated versus enteral feedings as tolerated alone immediately post traumatic injury.
Primary: To determine that early and adequate nutritional support will improve protein economy in the first week post -injury as measured by nitrogen balance. We hypothesize that an improvement in nitrogen balance with early maximized protein intake will support the production of acute phase proteins, major antioxidants and the inflammatory response.
Secondary: Through the use of mass spectrometry (MS) and nuclear magnetic resonance (NMR) technologies we will determine that our plan for early and adequate nutritional support with adequate protein from day one post injury will alter the metabolomics profile when compared to routine nutritional support.
Tertiary: For Specific Aim 3 we will measure several pro- and anti-inflammatory cytokines and soluble proteins.
详细描述
- Subjects admitted to the trauma service and cared for in the SICU will be screened for participation in this study.
- If subjects meet eligibility criteria, they will be enrolled and randomized 1:1 to enteral nutrition alone or enteral nutrition plus Amino Acid (AA) infusions.
- Nutritional assessment will be completed.
- Various procedures/assessments will take place over the course of the trial.
- Subjects will be followed for 28 days or until discharged or disposition of status.
Potential subjects deemed eligible will be randomized by the REDCap Randomization Module and begin study interventions within the first 24 hours of admission to the Surgical Intensive Care Unit (SICU).
Subjects enrolled into the Control Arm will receive routine nutritional support (RNS). RNS for the purpose of this study is defined as:
- Nutrition delivered via the enteral route of administration;
- Enteral caloric goal of 60-80% of energy requirements;
- Enteral feedings to be initiated as soon as medically feasible;
- Full parenteral nutrition to be initiated on Day 7 if enteral nutrition has not been started. Subjects will complete the study after Day 5 and will continue with nutritional support as clinically indicated.
Subjects enrolled into the Experimental Arm will receive RNS plus supplemental intravenous amino acids (RNS+IVAA). RNS+IVAA for the purpose of this study is defined as:
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
- None
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
- •Trauma Patient /Male or female, any race/ethnicity
- •Expected to survive 72 hours
- •Admitted to the SICU
- •Expected to remain in the hospital for at least 7 days
- •Candidates for enteral nutrition post-injury
排除标准
- •BMI less than 18 mg/m2 or greater than 35 mg/m2
- •Immunosuppressive disorders (i.e. Prednisone >20mg daily; Organ Transplant Recipient with active immunosuppression treatments, diagnosis of HIV/AIDS).
- •Type I or Type II Diabetes
- •Pregnancy
- •Pre-existing renal dysfunction (creatinine >2.5mg/dL).
- •Clear contraindication for enteral nutrition immediately post injury
- •Severe liver dysfunction (Total Bilirubin > 3.0mg%)
- •Non-English speaking patients
- •Known allergies to any of the study drug's components
研究组 & 干预措施
Experimental Group
Routine Nutritional Support plus supplemental IV amino acids, to begin within 24h of injury. (Target approximately 1.5-2g protein/kg/day)
干预措施: Routine Nutritional Support plus supplemental IV amino acids (Drug)
Control Group
Routine Nutritional Support (i.e. enteral nutrition as tolerated, to begin as early as medically feasible)
干预措施: Routine Nutritional Support (Other)
结局指标
主要结局
Nitrogen balance and Catabolic Index
时间窗: 8 days
We will use the urine specimen collections to measure nitrogen balance and catabolic index, both of which assess the level of physiologic stress. A catabolic Index less than zero represents no significant stress, an index greater than or equal to zero and less than or equal to 5 represents moderate stress, and an index greater than 5 represents severe stress. Twenty-four hour urine collections will be done for measurement of urine urea nitrogen to estimate nitrogen balance on day 1 and day 5 or 6 or 7 of the study. This will allow us to compare degree of catabolism and nitrogen efficiency between groups as well as between the two time points (Day 1 and Day 5 or 6 or 7). We hypothesize the early and adequate protein feeding group, although receiving fewer overall calories than subjects' total requirements, will have less negative nitrogen balance than the control group.
次要结局
- Metabolomics Profiles(8 days)