NCT01749488撤回不适用
The Impact of Involving a Dietitian in the Implementation of Expert Recommendations Concerning Nutrition During Intensive Care on Energy Balance
Centre Hospitalier Universitaire de Nīmes0 个研究点开始时间: 2015年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Caloric deficit accumulated over 7 days
研究概览
简要总结
The main objective of this study is to evaluate the impact of the intervention of a dietician on the energy balance accumulated over seven days of intensive care.
Energy balance is defined as the difference between the target recommended energy and total calorie intake actually received.
This is a randomized-cluster study; participating centers are randomized into experimental and control groups.
详细描述
The secondary objectives of this study are to compare the impact of the intervention of a dietician on:
- daily and accumulated energy balance at the end of the intensive care unit (ICU) stay
- deficits in protein intake per day, accumulated over 7 days, and accumulated for the ICU stay
- intake of vitamins, trace elements and pharmaco-nutrients per day
- predominant route of nutrition administration (enteral / parenteral / mixed)
- the course of the stay: duration of mechanical ventilation, organ failure, the ICU stay, number of days on antibiotics
- the presence / absence of complications: mortality, on catheter bacteremia, ventilator acquired pneumonia, other infections, bedsores, episodes of hyper-or hypoglycemia
- presence/absence of diarrhea
- costs related to the management of malnourished patients in terms of enteral and parenteral nutritional therapy, dietary supplements, antibiotics and sedatives as well as the costs of ICU stay and those related to diarrhea and sores
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •The patient must be insured or beneficiary of a health insurance plan
- •Patients hospitalized in intensive care for an expected period greater than 72 hours, and for whom sufficient eating after 72 hours of hospitalization is deemed unlikely upon admission.
- •Patients receiving mechanical ventilation and having at least one organ failure other than respiratory failure, defined by a SOFA score greater than 2.
排除标准
- •The patient is under judicial protection
- •The patient (or his/her legal representative or "trusted-person") indicates they do not wish to participate in the study
- •It is impossible to correctly inform either the patient or his/her "trusted person"
- •The patient is participating in another study, or is in an exclusion period determined by another study
- •Moribund patients or those for whom death appears imminent (within 24 hours)
- •Survival to Day 28 unlikely due to uncontrollable comorbidities
- •Patients with advanced directives issued expressing the wish to not be resuscitated
研究组 & 干预措施
Control intensive care wards
No Intervention
This is a randomized cluster trial. The centers randomized into this arm will serve as controls. No interventions will be implemented for these centers.
Experimental intensive care wards
Experimental
This is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care.
Intervention: Designated dietitian for the ward
干预措施: Designated dietitian for the ward (Other)
结局指标
主要结局
Caloric deficit accumulated over 7 days
时间窗: Day 7
Caloric deficit accumulated over 7 days (kcal/kg)
次要结局
- Caloric deficit accumulated during the ICU stay(ICU discharge (maximum of 28 days))
- Average per day amounts of trace elements received(Day 7)
- Number of days spent with (any) organ failure(ICU discharge (maximum of 28 days))
- Presence/absence of other infections(ICU discharge (maximum of 28 days))
- Presence/absence of a glycemia measure > 1.8 g/l(ICU discharge (maximum of 28 days))
- Average per-day protein deficit(Day 7)
- Mortality (yes/no)(Day 180)
- Presence/absence of on-catheter bacteremia(ICU discharge (maximum of 28 days))
- Presence/absence of ventilator acquired pneumonia(ICU discharge (maximum of 28 days))
- Minimum observed glycemia(ICU discharge (maximum of 28 days))
- Average observed glycemia(ICU discharge (maximum of 28 days))
- Presence/absence of hypertriglyceridemia(ICU discharge (maximum of 28 days))
- Presence/absence of diarrhea(Between Day 0 and ICU discharge (expected maximum of 28 days))
- Percentage of calories received by enteral route(ICU discharge (maximum of 28 days))
- Percentage of proteins received by enteral route(ICU discharge (maximum of 28 days))
- Maximum observed glycemia(ICU discharge (maximum of 28 days))
- Presence/absence of a glycemia measure < 0.4 g/l(ICU discharge (maximum of 28 days))
- Accumulated cost of enteral nutrition(Between Day 0 and ICU discharge (expected maximum of 28 days))
- Protein deficit accumulated over 7 days(Day 7)
- Average per day amounts of vitamins received(Day 7)
- Average per day amounts of pharmaco nutrients received(Day 7)
- length of ICU stay (days)(ICU discharge (maximum of 28 days))
- Presence/absence of bed sores(ICU discharge (maximum of 28 days))
- Accumulated cost of parenteral nutrition(Between Day 0 and ICU discharge (expected maximum of 28 days))
- Average per day caloric deficit(Day 7)
- Protein deficit accumulated during the ICU stay(ICU discharge (maximum of 28 days))
- length of time spent on ventilator (hours)(ICU discharge (maximum of 28 days))
- Number of days on antibiotics(ICU discharge (maximum of 28 days))
- Composite score for complications(ICU discharge (maximum of 28 days))
- Accumulated cost of antibiotics(Between Day 0 and ICU discharge (expected maximum of 28 days))
- Accumulated cost of ICU stay(Between Day 0 and ICU discharge (expected maximum of 28 days))
- Accumulated cost of sedation(Between Day 0 and ICU discharge (expected maximum of 28 days))
- Accumulated cost of nutritional supplements(Between Day 0 and ICU discharge (expected maximum of 28 days))
- Percentage of calories received by enteral route(Day 7)
- Percentage of proteins received by enteral route(Day 7)
- Mortality (yes/no)(Day 90)
- Presence/absence of on-catheter bacteremia(Day 7)
- Presence/absence of on-catheter bacteremia(Day 28)
- Presence/absence of ventilator acquired pneumonia(Day 7)
- Presence/absence of ventilator acquired pneumonia(Day 28)
- Presence/absence of other infections(Day 7)
- Presence/absence of other infections(Day 28)
- Presence/absence of bed sores(Day 7)
- Presence/absence of bed sores(Day 28)
- Presence/absence of hypertriglyceridemia(Day 7)
- Composite score for complications(Day 7)
- Composite score for complications(Day 28)
- Minimum observed glycemia(Day 7)
- Maximum observed glycemia(Day 7)
- Average observed glycemia(Day 7)
- Presence/absence of a glycemia measure < 0.4 g/l(Day 7)
- Presence/absence of a glycemia measure > 1.8 g/l(Day 7)
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