A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
The aim of the study is to assess the efficacy and tolerability of the low-volume supplement. The investigators randomized critically ill patients to receive Intestamin plus Fresubin or Fresubin alone.
Systemic Inflammatory Response Syndrome
Dietary Supplement: Fresubin Original
Dietary Supplement: Intestamin plus Fresubin Original
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Prospective, Controlled, Double-blind, Single-center Pilot Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)|
- Length of stay in ICU [ Time Frame: 14 days ] [ Designated as safety issue: No ]The primary endpoints were length of stay in ICU and sufficient enteral feed.
- mortality [ Time Frame: 14 days ] [ Designated as safety issue: No ]Secondary endpoints were APACHE score, days of fever, artificial ventilation, and antibiotics, mortality, catecholamine need, inflammation parameters (CRP, leukocytes, etc.), pneumonia with detection of bacteria, need for insulin, and length of hospital stay.
|Study Start Date:||February 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: Fresubin Original||Dietary Supplement: Fresubin Original|
|Experimental: Intestamin plus Fresubin Original||Dietary Supplement: Intestamin plus Fresubin Original|
To compare early supplementation with antioxidants and glutamine using an enteral pharmaconutrition supplement (Intestamin®) to an energy adjusted standard elementary diet and to investigate its affect on clinical efficacy and tolerability in critically ill patients with sepsis/SIRS.
Methods: This was a prospective controlled randomized study in 58 critically ill patients. They received either Intestamin or a diluted Fresubin solution. After 10 or 14 days inflammatory parameters, catecholamine need, and maximal enteral delivery were determined.