The Enteral Resuscitation In Intensive Care (ERI) Pilot- Study: Enteral Versus Intravenous Fluid Administration in the Treatment of Critically Ill Patients: a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- 30-day mortality
研究概览
简要总结
The purpose of this pilot study is to overcome the limited evidence on enteral fluid administration in intensive care medicine and to generate data for further hypothesis generation in an exploratory setting. This trial is a prospective, multicenter, randomized, parallel group, open-label study to compare the current standard of practice, the intravenous fluid administration, with a more physiological approach, the enteral fluid administration, in critically ill patients.
详细描述
Introduction
The effectiveness and safety of enteral fluid administration in critically ill patients remains unclear. Existing evidence regarding this topic is scarce, but suggests that enteral fluid administration is a safe route of administration. To our knowledge no randomized controlled trial has been conducted investigating this topic.
Objectives: The aim of this pilot study is to gather evidence on the impact of enteral fluid replacement on clinical, laboratory and outcome parameters in intensive care patients in order to plan a subsequent larger randomized controlled trial. Clinical outcomes indices evaluated are regurgitation, thirst, serum sodium, mortality, length of mechanical ventilation arterial pressure, urinary volume, body weight, edema, intra-abdominal pressure), changes in bioimpedance spectroscopy-derived markers, fluid overload, renal function tests, liver function tests and SOFA-Scores.
Methods: The trial is a prospective, multicenter, randomized, parallel group, open-label study. Patients are going to be recruited and randomized at 3 separate internal medicine intensive care units in Vienna, Austria. A total of 64 patients will be recruited and randomized to receive enteral fluid administration via nasogastric tube or intravenous administration only. Daily visits and evaluation of clinical and radiological fluid status is performed by the attending physician. Regular study visits with Bioimpedance spectroscopy measurements (BIS) to evaluate fluid status are going to be performed
Results and conclusions: The ERI study will provide data on potential outcome parameters to plan a subsequent larger randomized control trial for patients receiving enteral fluid therapy in intensive care medicine.
Ethics and dissemination: The trial is performed in accordance with the Declaration of Helsinki. It subscribes to the principles outlined in the most recent version of the International Conference on Harmonization on Good Clinical Practice. Approval was obtained from the ethics committee of the Medical University of Vienna (EK number 1790/2020). The study has also been registered in a public clinical trial database (EudraCT Identifier Number 2018-002447-29, clinicaltrialsregister.eu).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intravenous Fluid Arm
In Group 1 (Standard of practice/intravenous fluid group) no enteral administration of fluid other than enteral nutrition is going to be allowed. Intravenous fluid administration is going to be administered at the discretion of the physician in charge and "Elomel isoton" is going to be the fluid of choice.
干预措施: Intravenous Infusion (Drug)
Enteral Fluid Arm
In Group 2 (Test practice/enteral fluid group) enteral fluid administration is going to be the primary mode of administration. Intravenous fluid administration can be performed by physicians at their own discretion. Primary enteral fluid administered is going to be tap water, intravenous fluid of choice is going to be "Elomel isoton".
干预措施: Enteral Dose Form (Drug)
结局指标
主要结局
30-day mortality
时间窗: From the moment of intubation until 30 days after intubation
30-day mortality
Regurgitation
时间窗: From the moment of intubation to extubation.
Incidence and extent of regurgitation via the stomach/jejunal probe
Sodium/Osmolality
时间窗: From the moment of intubation to extubation.
Differences of serum sodium and serum osmolality
Days on ventilation
时间窗: From the moment of intubation to extubation.
Days on ventilation
Thirst
时间窗: On the last study visit (day of extubation)
Thirst on a zero to 10 numeric rating scale (NRS; worst = 10)
次要结局
- SOFA-Score(From the moment of intubation to extubation)
- BCM(From the moment of intubation to extubation)
- Kidney Failure(From the moment of intubation to extubation.)
研究者
Assoc. Prof. Dr. Manfred Hecking, MD PhD
Principal Investigator
Medical University of Vienna