Patients on ICU require fluid substitution
Conditions
Interventions
Trade Name: ELO-MEL isoton
Product Name: ELO-MEL isoton
Pharmaceutical Form: Gastroenteral liquid
Other descriptive name: SODIUM ACETATE
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Sponsors
Medizinische Universität Wien, klinische Abteilung für Nephrologie und Dialyse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Newly intubated patients (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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In order to obtain data for the design of a future confirmatory randomized controlled trial, this pilot study aims to evaluate differences between gastroenterally and intravenously fluid-substituted patients with regard to - clinical outcomes indices (such as regurgitation, thirst, serum sodium, arterial pressure, urinary volume, body weight, edema, intra-abdominal pressure) - changes in bioimpedance spectroscopy-derived markers ;Secondary Objective: - to compare the incidence of regurgitation via the stomach/jejunal probe in both cohorts - to compare fluid overload and other measurements of fluid volume status in both cohorts - to compare the incidence of acute kidney failure in both cohorts - to compare the incidence of liver failure in both cohorts - to compare length of mechanical ventilation in both cohorts - to compare the mortality in both cohorts - to compare the SOFA scores in both cohorts;Primary end point(s): regurgitation, arterial pressure, urinary volume, body weight, edema, intra-abdominal pressure, thirst, serum sodium, changes in bioimpedance spectroscopy-derived markers between gastroenterally and intravenously fluid-substituted patients in order to obtain data for the design of a future randomized controlled trial;Timepoint(s) of evaluation of this end point: Once daily | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): incidence of regurgitation via the stomach/jejunal probe, fluid overload and other measurements of fluid volume status, incidence of acute kidney failure and liver failure, length of mechanical ventilation, mortality, hospitalizations and other clinical events ;Timepoint(s) of evaluation of this end point: This timepoint is unclear. | — |
Countries
Austria
Contacts
Public ContactSupawadee Payomnoi
Clinical Trials Coordination Centre
Outcome results
None listed