MedTrace Logo

The Enteral Resuscitation In Intensive Care Pilot- Study

NCT05595395 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-10-25

No results posted yet for this study

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

Interventions

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".

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".

Sponsors & Collaborators

  • Klinik Favoriten

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Manfred Hecking, M.D. · Medical University of Vienna, Department of Nephrology and Dialysis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2024-12-01
Completion
2025-06-01

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05595395 on ClinicalTrials.gov