Comparative surveillance study to assess the effect of lipid based nutrition vs. standard regimen on clinical outcome in ventilated patients.
- Conditions
- The aim of the presented surveillance is to confirm the results of the pilot study showing a significant reduction in respirator days and ICU-stay in patients with lipid based nutrition compared to standard regimen. Additionally parameters of immunological, inflammatory and illness status between patients with lipid based nutrition and patient with standard regime will be acquired and compared.
- Registration Number
- EUCTR2007-003311-32-DE
- Lead Sponsor
- FORIM GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Age: >18 and = 70 years
Indication to receive artificial ventilation for at least 10 days.
Oral or enteral nutrition is expected to deliver not more than 30 % of the total
Energy needs on day 5 after inclusion.
Patient able and willing to sign assumed consent; if patient is not able, the
egally authorized representative has to sign a written informed consent.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Pregnant or lactating females.
Any concomitant illness or abnormal laboratory test which, in the investigator's opinion, would render the patient unsuitable for enrolment.
Current therapy that excludes the use of study treatment.
Diabetes Type I and II
Long term sedation with Propofol.
Known alcohol or drug abuse.
Known hypersensitivity to the product or excipients.
Participation in another clinical drug study.
Patients treated with corticoids, cytotoxic drugs, cancer, HIV
Age < 18 years >70
Patients with a gcs score at the scene of accident
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method