Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT05595395
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05595395
Study Brief:
Protocol Section:
NCT05595395