The Enteral Resuscitation In Intensive Care Pilot- Study

NCT ID: NCT05595395

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2025-06-01

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).

Conditions

Electrolyte Imbalance; Volume Overload; Hyperosmolality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Intravenous Infusion

Intervention Type: 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".

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".

Group Type: ACTIVE_COMPARATOR

Enteral Dose Form

Intervention Type: 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".

Interventions

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".

Intervention Type: DRUG

Intravenous Infusion

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".

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klinik Favoriten

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Assoc. Prof. Dr. Manfred Hecking, MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manfred Hecking, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Nephrology and Dialysis

Locations

Klinik Favoriten

Vienna, , Austria

Site Status: RECRUITING

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

Vienna, , Austria

Site Status: NOT_YET_RECRUITING

Countries

Austria

Central Contacts

Manfred Hecking, MD, PhD

Role: CONTACT

manfred.hecking@meduniwien.ac.at

0043-699-10580831

Univ. Klinik für Innere Medizin III

Role: CONTACT

postakhi3m@akhwien.at

0043 1 40400-62090

Facility Contacts

Nikolaus Keil, MD

Role: primary

nikolaus.keil@meduniwien.ac.at

Maximilian Waller, MD

Role: backup

maximilian.waller@meduniwien.ac.at

Manfred Hecking, MD

Role: primary

manfred.hecking@meduniwien.ac.at

Other Identifiers

EK Nr. 1790/2020

Identifier Type: -

Identifier Source: org_study_id