Clinical trial NCT05595395: The Enteral Resuscitation In Intensive Care Pilot- Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Electrolyte Imbalance
Volume Overload
Hyperosmolality
Keywords: Fluid Therapy
Critical Care
Prospective Studies
Pilot Project
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Klinik Favoriten
First posted: 2022-10-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, explorative, multicenter, randomized, parallel group, open-label study
Primary purpose: TREATMENT

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).

Eligibility criteria: * Inclusion criteria:

  * Patient intubated within the last 72h
  * Age \>18 years
  * Expected required fluid volume may not exceed 4 mL/kg/h (permanently, during at least 24 hours).
  * Negative pregnancy test in female patients of childbearing potential
  * Informed consent. For patients that are temporarily unable to consent a
  * subsequent informed consent must be provided.
* Exclusion criteria:

  * Evidence of severe gastrointestinal disease defined as

    * Gastrointestinal Failure with \> 3 symptoms (see below) or
    * Lactate \>3mmol/L when mesenterial ischemia is a probable cause
    * Clinical signs of intra-abdominal hypertension and an increase of intra-abdominal pressure of \>20 mmHg.
  * Patients who cannot receive early enteral nutrition due to conditions such as prone positioning in consequence of conditions such as acute respiratory distress syndrome
  * Pregnancy
  * Abdominal surgery in the last 3 months (unless all involved physicians, study investigators and caretaking doctors agree that the surgical event does not constitute a limitation for enteral fluid administration)
  * Postoperative patients with consecutive admission to ICU
  * Extracorporeal Kidney-Replacement Therapy before intubation
  * At the discretion of the Investigator

Symptoms of Gastrointestinal Failure:

* Absent bowel sounds
* Bowel distension
* Vomiting/regurgitation volume \>500 ml
* GI bleeding
* Diarrhoea (liquid stool \>3 times a day)
* Distended stomach on ultrasound examination.

Primary outcomes:
measure: Regurgitation
timeFrame: From the moment of intubation to extubation.
measure: Sodium/Osmolality
timeFrame: From the moment of intubation to extubation.
measure: Thirst
timeFrame: On the last study visit (day of extubation)
measure: Days on ventilation
timeFrame: From the moment of intubation to extubation.
measure: 30-day mortality
timeFrame: From the moment of intubation until 30 days after intubation
Secondary outcomes:
measure: Kidney Failure
timeFrame: From the moment of intubation to extubation.
measure: SOFA-Score
timeFrame: From the moment of intubation to extubation
measure: BCM
timeFrame: From the moment of intubation to extubation
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Klinik Favoriten
city: Vienna
country: Austria
facility: Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria
Study officials:
affiliation: Medical University of Vienna, Department of Nephrology and Dialysis
name: Manfred Hecking, M.D.
role: PRINCIPAL_INVESTIGATOR
References: