An interventional study of Enteral Dose Form and Intravenous Infusion in Electrolyte Imbalance, Volume Overload and Hyperosmolality, sponsored by Medical University of Vienna. Recruiting at 2 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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.
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).
Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient intubated within the last 72h
Evidence of severe gastrointestinal disease defined as
Symptoms of Gastrointestinal Failure:
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.
Drug: Intravenous Infusion
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".
Drug: Enteral Dose Form
In this intervention arm, fluid substitution is primarily done via enteral administration. The used substance for enteral fluid administered is going to be tap water. Intravenous fluid of choice is going to be "Elomel isoton".
In this intervention arm, fluid substitution is primarily done via intravenous administration. The used substance for intravenous fluid administered is going to be "Elomel isoton".
Regurgitation
Incidence and extent of regurgitation via the stomach/jejunal probe
Time frame: From the moment of intubation to extubation.
Sodium/Osmolality
Differences of serum sodium and serum osmolality
Time frame: From the moment of intubation to extubation.
Thirst
Thirst on a zero to 10 numeric rating scale (NRS; worst = 10)
Time frame: On the last study visit (day of extubation)
Days on ventilation
Days on ventilation
Time frame: From the moment of intubation to extubation.
30-day mortality
30-day mortality
Time frame: From the moment of intubation until 30 days after intubation
Kidney Failure
Incidence and extent of kidney failure as well as kidney function
Time frame: From the moment of intubation to extubation.
SOFA-Score
Differences of Sequential Organ Failure Assessment (SOFA) Scores of patients. This score includes PaO2 \[mmHg\], FiO2 \[%\], mechanical ventilation \[Yes/No\], Platelets \[/µL\], Glascow Coma Scale, Bilirubin \[mg/dL\], Mean arterial pressure OR administration of vasoactive agents required and creatinine \[mg/dL\]. The score ranges from 0=best to 24=worst.
Time frame: From the moment of intubation to extubation
BCM
Differences in fluid volume status including Bioimpedance spectroscopy measurements (BIS) using Body Composition Monitor (BCM)
Time frame: From the moment of intubation to extubation
Plan to share: No
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Medical University of Vienna