The Effect of Continuous Versus Intermittent Enteral Nutrition on Metabolic Outcomes in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 5
- 主要终点
- Glycaemic variability
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of continuous versus intermittent enteral nutrition on metabolic outcomes in critically ill adult patients.
The aim of this study is to:
• To assess the effect of a daytime intermittent tube feeding pattern compared to standard continuous tube feeding on glycaemic control, gastrointestinal function, gastrointestinal hormones, markers of sleep quality and circadian rhythm, and lean body mass and body composition.
Participants will receive either continuous enteral nutrition for 24 hours a day or intermittent enteral nutrition during the day, consisting of 4 portions each administered over 1 hour between 8 am and 8 pm. The maximum duration of the intervention is 5 days or until participants do not receive exclusive gastric enteral nutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥18 years;
- •Receiving or eligible to receive exclusively gastric tube feeding;
- •Expected ICU stay ≥48 hours;
- •Receiving or anticipated to receive invasive mechanical ventilation within 48 hours after ICU admission.
排除标准
- •The treating clinician considers participation in the study clinically contraindicated (e.g., change in feeding regimen, no possibility for placement of CGM on arms, not able to receive exclusive gastric tube feeding);
- •Death is deemed to be imminent or inevitable during admission, and the attending doctor, patient, or substitute decision-maker is not committed to active treatment;
- •Expected fasting for ≥12 hours during the study period, for example, due to medical procedures;
- •Readmission in last 14 days;
- •Patients with burn injuries;
- •Participating in another nutritional intervention study.
研究组 & 干预措施
Continuous enteral nutrition
Participants will receive the standard of care, continuous enteral nutrition for 24 hours a day.
Intermittent enteral nutrition
Participants will receive intermittent enteral nutrition in four separate portions between 8:00 a.m. and 8:00 p.m. Each portion will be administered over a one-hour period.
干预措施: Intermittent enteral nutrition (Other)
结局指标
主要结局
Glycaemic variability
时间窗: From enrollment to the end of the intervention at a maximum of 5 days.
The primary outcome is the mean glycaemic variability per 24 hours during the intervention, measured with Continuous Glucose Monitoring (CGM), expressed as the Coefficient of Variation (COV). The COV is calculated by dividing the standard deviation by the mean blood glucose level and multiplying by 100. It gives a relative measure of variability, which is helpful in comparing variability between individuals or groups with different mean glucose levels.
次要结局
- Circadian rhythm(Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.)
- Gastrointestinal tolerance during the intervention period(From enrollment to the end of the intervention at a maximum of 5 days.)
- Glycaemic control(From enrollment to the end of the intervention at a maximum of 5 days)
- Insulin administred during intervention period(From enrollment to the end of the intervention at a maximum of 5 days)
- Dysglycemic events during intervention period(From enrollment to the end of the intervention at a maximum of 5 days)
- Gastrointestinal tolerance during the intervention period(From enrollment to the end of the intervention at a maximum of 5 days)
- Body composition(Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.)
- Muscle size(Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.)
- Nutritional intake during intervention period(From enrollment to the end of the intervention at a maximum of 5 days.)
- Non-nutritonal calories administred during intervention period(From enrollment to the end of the intervention at a maximum of 5 days)
- Health-related quality of life(60 days after ICU admission)
- Sleep quality(60 days after ICU admission)
- Glucoregulatory gastrointestinal hormones(From 12:00 until 14:00 on the second study day.)
研究者
ARH van Zanten, MD PhD
Internist-intensivist, Medical Head of ICU and Research
Gelderse Vallei Hospital