The Safety and Feasibility of a 12-hour Time-Limited Enteral Feeding Protocol in Critically Ill Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and feasibility
研究概览
简要总结
This study is being done to assess the feasibility and safety of a time-restricted 12-hour enteral feeding protocol (experimental group) in comparison to a standard-of-care, 24-hour enteral feeding protocol (control group) in critically ill patients. Investigators hope to gain knowledge about how these feeding schedules affect feeding tolerance, blood sugar control, and other factors affecting critically ill adult patients.
- Investigators expect that the 12-hour feeding protocol will be tolerated similarly to the 24-hour feeding protocol and will not result in a greater number of adverse events related to feeding.
- Investigators expect that the proportion of participants in both groups receiving at least 75% of their estimated nutrition needs will be similar.
详细描述
Investigators will test a 12-hour time-restricted feeding (TRF12) protocol in critically ill adults and compare this to a standard-of-care, 24-hour continuous feeding (CONT24) schedule. Time-restricted feeding (TRF) is form of intermittent fasting involving eating within a consistent, shortened period each day, following by fasting for at least 12 hours daily. TRF may improve glycemic control, blood pressure, and circadian rhythms in metabolism relative to feeding over a longer period. In critically ill patients, most facilities feed enterally over 24-hours which may exacerbate sleep disturbances and post-intensive care syndrome. In addition to safety and feasibility measures, this 10-day trial will gather preliminary data regarding how these feeding protocols each affect glycemic control, sleep, and long-term effects of critical care, such as delirium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
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
- •Adults (≥18 years of age)
- •With critical illness (hospitalized in an intensive care unit with a status of "ICU")
- •Who have received orders for continuous enteral nutrition
排除标准
- •"Comfort Measures Only" status
- •Have orders to receive trickle feedings (feeding rate ≤10mL/hr)
- •Recent surgical procedure on the GI tract (within previous 5 days at time of recruitment) or admission for GI bleed
- •Receiving continuous sedation
- •Expected to undergo a procedure requiring removal of study devices in the three days following enrollment
- •History of malabsorptive bariatric surgery
- •Admitted for a burn injury
- •Known intolerance to feeding rates >100mL/hr
- •Current diagnosis of pancreatitis, ileus or gastroparesis (only if using a gastrostomy tube)
- •Requiring intermittent or continuous renal replacement therapy
- •Pregnant or lactating
- •On an intermittent feeding schedule
- •Nutritional needs would require a rate higher than 120mL/hr on TRF12 protocol
- •Lack of clearance by primary physician
研究组 & 干预措施
Continuous 24 hour feeding (CONT24).
24 hour tube feeding is the standard of care. They will receive tube feeding continuously over 24 hours daily.
干预措施: Continuous 24 hour feeding (CONT24). (Other)
12-hour time-restricted feeding (TRF12)
The 12-hour time-restricted feeding group will receive the same amount of nutrition in 12 hours as would be needed in 24 hours. The hourly feeding rate will double.
干预措施: 12-hour time-restricted feeding (TRF12) (Other)
结局指标
主要结局
Safety and feasibility
时间窗: From randomization up to 10 days
Safety will be measured by the need for pausing or discontinuing enteral feeds, gastrointestinal complications (including vomiting, abdominal distention, and diarrhea), other feeding complications (e.g., aspiration, gastric residuals), and hypoglycemic events. Feasibility is defined as the percentage of patients who received ≥75% of their prescribed nutrition goal, and the logistical feasibility of collecting study data.
次要结局
- Glycemic control(From randomization up to 10 days)
- Sleep quantity(From randomization up to 10 days)
- Circadian rhythm of skin surface temperature(From randomization up to 10 days)
研究者
Felicia Steger
Principal Investigator
University of Kansas Medical Center