The Enteral Resuscitation In Intensive Care Pilot- Study

Not Applicable

Recruiting

• Conditions: Electrolyte Imbalance; Volume Overload; Hyperosmolality
• Interventions: Drug: Enteral Dose Form; Drug: Intravenous Infusion

• Registration Number: NCT05595395
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2022-10-22
• Study First Submitted QC: 2022-10-22
• Study First Posted: 2022-10-27
• Study Start: 2023-02-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-21
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteral Fluid Arm	Enteral Dose Form	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".
Intravenous Fluid Arm	Intravenous Infusion	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.

Primary Outcome Measures

Name	Time	Method
30-day mortality	From the moment of intubation until 30 days after intubation	30-day mortality
Regurgitation	From the moment of intubation to extubation.	Incidence and extent of regurgitation via the stomach/jejunal probe
Sodium/Osmolality	From the moment of intubation to extubation.	Differences of serum sodium and serum osmolality
Days on ventilation	From the moment of intubation to extubation.	Days on ventilation
Thirst	On the last study visit (day of extubation)	Thirst on a zero to 10 numeric rating scale (NRS; worst = 10)

Secondary Outcome Measures

Name	Time	Method
SOFA-Score	From the moment of intubation to extubation	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.
BCM	From the moment of intubation to extubation	Differences in fluid volume status including Bioimpedance spectroscopy measurements (BIS) using Body Composition Monitor (BCM)
Kidney Failure	From the moment of intubation to extubation.	Incidence and extent of kidney failure as well as kidney function

Trial Locations

Locations (2)

Klinik Favoriten; 🇦🇹 Vienna, Austria

Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria; 🇦🇹 Vienna, Austria