Comparing enteral and intravenous fluid administration in critically ill patients
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
This study is testing whether giving fluids through a tube in the stomach works better and is safer than giving fluids through an IV for critically ill patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 2 sites (Vienna and 1 other locations) |
| Trial ID | NCT05595395 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to investigate the effectiveness and safety of enteral fluid administration compared to standard intravenous fluid administration in critically ill patients. It is a prospective, multicenter, randomized, parallel group, open-label study conducted at three intensive care units in Vienna, Austria. A total of 64 patients will be recruited and randomized to receive either enteral fluids via nasogastric tube or intravenous fluids only, with various clinical and laboratory parameters being monitored to assess outcomes. The study seeks to generate data that could inform larger randomized controlled trials in the future.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients aged over 18 who have been intubated within the last 72 hours and require limited fluid volume.
Not a fit: Patients with severe gastrointestinal disease or those unable to receive early enteral nutrition due to specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method of fluid administration for critically ill patients.
How similar studies have performed: While existing evidence on enteral fluid administration is limited, this approach has not been previously tested in a randomized controlled trial setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vienna and 1 other locations
- Klinik Favoriten — Vienna, Austria (Recruiting)
- Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria — Vienna, Austria (Not_yet_recruiting)
Study contacts
- Principal investigator: Manfred Hecking, M.D. — Medical University of Vienna, Department of Nephrology and Dialysis
- Study coordinator: Manfred Hecking, MD, PhD
- Email: manfred.hecking@meduniwien.ac.at
- Phone: 0043-699-10580831
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.