THE ENTERAL RESUSCITATION IN INTENSIVE CARE STUDY

Phase 1

• Conditions: Patients on ICU require fluid substitution; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2018-002447-29-AT
• Lead Sponsor: Medizinische Universität Wien, klinische Abteilung für Nephrologie und Dialyse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-10
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

(1) Newly intubated patients (<72h)
(2) Age >18 years
(3) Amount of fluid substitution was within the range as defined for the respective disease per Table 2 in clinical study protocol
(4) Negative pregnancy test in female patients of childbearing potential
(5) Informed consent
(6) Expected required fluid volume may not exceed 4 mL/kg/h (permanently, during at least 24 hours)
(7) For patients that are temporarily unable to consent a subsequent informed consent has to be provided.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

(1) Evidence of severe gastrointestinal disease defined as:
- Gastrointestinal Failure score > 3 or
- lactate >3mmol/L when mesenterial ischemia is a probable cause or
- intraabdominal pressure >20mmHg or increase under enteral fluid/nutrition administration)
(2) Patients who cannot receive early enteral nutrition due to conditions such as prone positioning in consequence of conditions such as acute respiratory distress syndrome
(3) Pregnancy
(4) 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)
(5) Postoperative patients
(6) At the discretion of the Investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified