The Enteral Resuscitation In Intensive Care Pilot- Study

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborator: Klinik Favoriten

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.