GuiDIng Energy Provision Using indiREct CalorimeTry: a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Feasibility: Treatment separation in energy adequacy
研究概览
简要总结
The DIRECT trial is a prospective, multi-centre, two arm parallel feasibility pilot randomised controlled trial. The primary aim is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity.
The trial will recruit 60 mechanically ventilated patients from 4-6 ICUs in Australia and New Zealand.
详细描述
Indirect calorimetry is the current reference standard for measuring energy expenditure during critical illness, allowing for personalisation of energy delivery. Use of indirect calorimetry may be important in mitigating under- and overfeeding and associated adverse outcomes. This may be particularly important in patients with obesity, where energy expenditure is difficult to estimate, and limited data is available on the optimal nutritional management of this subgroup.
Although access to indirect calorimetry is gradually improving, it remains an underutilised tool and skills required to complete and interpret measurements are limited which may hinder use and integration into practice. There is a resulting knowledge gap on the impact of indirect calorimetry on outcomes in comparison to standard care predictive equations.
A definitive and pragmatic trial is needed to assess the impact of guiding energy delivery with indirect calorimetry on patient outcomes. Importantly, confirming the feasibility of using indirect calorimetry to guide energy delivery is needed to define optimal measurement protocols prior to completion of a larger trial.
The primary aim of the DIRECT trial is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity. The secondary aim is to inform a larger trial by collecting process, nutrition, functional, clinical and safety outcomes.
The investigators will consider the main trial feasible to conduct if 2 of the following 3 feasibility criteria are achieved: (a) recruitment rate is ≥ 1 patient per calendar month; (b) between group separation of ≥20% in energy adequacy during ICU admission is achieved in relation to measured energy expenditure and; (c) the number of indirect calorimetry measurements completed/planned ≥60% during ICU admission.
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
- None
盲法说明
Open-label trial. However, clinicians will be blinded to indirect calorimetry measurements in the control arm.
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
- •Adult (≥ 18 years) patients
- •Body mass index ≥30 kg/m2
- •Between day 3 and 6 of index ICU admission
- •Receiving invasive mechanical ventilation
- •Receiving enteral or parenteral nutrition
排除标准
- •Receiving extracorporeal membrane oxygenation support
- •Major burns (≥20% total body surface area)
- •Unable to perform indirect calorimetry within 24 hours of randomisation
- •Known pregnancy
- •Death is imminent
- •Treating clinician believes the study is not in the best interest of the patient
研究组 & 干预措施
Individualised energy delivery
Energy delivery will be guided by indirect calorimetry, with the aim to meet 80-100% of the most recent energy expenditure measurement from day 4 to 28 of hospital admission.
干预措施: Indirect calorimetry (Other)
Standard care nutrition
Energy delivery will be according to predictive equation estimates and usual site practice from day 4 to 28 of hospital admission.
干预措施: Indirect calorimetry (Standard care nutrition arm) (Other)
结局指标
主要结局
Feasibility: Treatment separation in energy adequacy
时间窗: During ICU admission (up to day 28)
Energy adequacy % will be calculated as daily energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage.
Feasibility: Protocol adherence
时间窗: During ICU admission (up to day 28)
Number of indirect calorimetry measurements completed/planned.
Feasibility: Recruitment rate
时间窗: During ICU admission (up to day 28)
Patients per site, per month
次要结局
- Treatment separation in energy adequacy(Post-ICU period (up to day 28))
- Protocol adherence(Post-ICU period (up to day 28))
- Reasons for indirect calorimetry measurement non-completion(Up to day 28)
- Clinician acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)(Up to day 28)
- Cumulative difference in energy delivery compared to prescribed energy expenditure(Day 28)
- Nutritional status(Baseline, ICU (up to day 28) and hospital discharge (up to day 28))
- Patient acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)(Up to day 28)
- Cumulative difference in energy delivery compared to measured energy expenditure(Day 28)
- Handgrip strength(Hospital discharge (up to day 28))
- Duration of mechanical ventilation(Day 28)
- ICU length of stay(Day 28)
- Hospital length of stay(Day 28)
- Survival(ICU discharge (up to day 28), in-hospital (up to day 28) and 90 day)
- European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L)(Day 90)
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS)(Day 90)