The Augmented Versus Routine Approach to Giving Energy Trial Metabolic Effects Sub-study (TARGET-ME)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Calorie difference in kcal
研究概览
简要总结
The estimation of calorie needs during routine practice in critically ill patients is highly variable and the thermogenic effect of continuous delivery of enteral nutrition (EN) on overall calorie utilisation in critically ill adults is unknown. The TARGET-ME study is a substudy of the TARGET trial (NCT02306746). The TARGET trial provides the perfect opportunity to measure calorie utilisation via indirect calorimetry (IC) and ventilator-derived carbon dioxide production (VCO2) to compare measured calorie utilisation to estimation methods, determine the potential thermic effect of EN solutions with different energy concentrations and investigate any associations with outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients must first meet the inclusion and none of the exclusion criteria for the TARGET main trail (NCT02306746). The following additional criteria applies for this study when indirect calorimetry is being used:
- •Within 48 hours of randomisation to TARGET (first measurement only)
- •Fi02 < 50% for the past 1 hour
- •Positive end expiratory pressure (PEEP) < 12 mmHg for the past 1 hour
- •The IC test can be conducted within 48 hours of randomisation to TARGET
- •The patient is not considered agitated using the usual site assessment
- •There is a clinician available to complete the test
排除标准
- •There is an air leak in the ventilation circuit (ie bubbling inter-costal catheters, cuff leak at the endotracheal tube
- •The patient is receiving renal replacement therapy or extracorporeal membrane oxygenation at the time of measurement
- •Has had surgery in the last 6 hours (if enough time within the 48 hour window, consider waiting until this criteria is less than 6 hours)
- •If the patient has a traumatic brain injury, for the previous 6 hours, their intracranial pressures have been unstable and in the opinion of the treating intensivist are not controlled
- •The treating clinician believes that the IC test will pose risk to the patient
结局指标
主要结局
Calorie difference in kcal
时间窗: Up to day 28
Difference in mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in each study group
次要结局
- Calorie difference in kcal in the whole study cohort(Up to day 28)
研究者
anzicrc
ICU Nutrition Research Program Manager
Australian and New Zealand Intensive Care Research Centre