The Enteral Resuscitation In Intensive Care Pilot- Study

NCT05595395 | Unknown

• 1 other identifier: EK Nr. 1790/2020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Electrolyte Imbalance; Volume Overload; Hyperosmolality

Keywords

Fluid Therapy; Critical Care; Prospective Studies; Pilot Project

Outcome Measures

Primary Outcomes (5)

• Regurgitation

  Incidence and extent of regurgitation via the stomach/jejunal probe

  From the moment of intubation to extubation.

• Sodium/Osmolality

  Differences of serum sodium and serum osmolality

  From the moment of intubation to extubation.

• Thirst

  Thirst on a zero to 10 numeric rating scale (NRS; worst = 10)

  On the last study visit (day of extubation)

• Days on ventilation

  Days on ventilation

  From the moment of intubation to extubation.

• 30-day mortality

  30-day mortality

  From the moment of intubation until 30 days after intubation

Secondary Outcomes (3)

• Kidney Failure

  From the moment of intubation to extubation.

• SOFA-Score

  From the moment of intubation to extubation

• BCM

  From the moment of intubation to extubation

Study Arms (2)

Intravenous Fluid Arm

PLACEBO COMPARATOR

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

Enteral Fluid Arm

ACTIVE COMPARATOR

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

Interventions

Enteral Dose Form DRUG

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".

Enteral Fluid Arm

Intravenous Infusion DRUG

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".

Intravenous Fluid Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Klinik Favoriten: collaborator

Study Sites (2)

Klinik Favoriten

Vienna, 1010, Austria

RECRUITING

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

Vienna, 1090, Austria

NOT YET RECRUITING

MeSH Terms

Conditions

Edema

Interventions

Infusions, Intravenous

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Manfred Hecking, M.D.

  Medical University of Vienna, Department of Nephrology and Dialysis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred Hecking, MD, PhD

CONTACT

0043-699-10580831; manfred.hecking@meduniwien.ac.at

Univ. Klinik für Innere Medizin III

CONTACT

0043 1 40400-62090; postakhi3m@akhwien.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, explorative, multicenter, randomized, parallel group, open-label study

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 27, 2022
• Study Start: February 13, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)