A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin) (Intestamin)
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|ClinicalTrials.gov Identifier: NCT01167075|
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Adult Sepsis Systemic Inflammatory Response Syndrome||Dietary Supplement: Fresubin Original Dietary Supplement: Intestamin plus Fresubin Original||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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)|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
|Active Comparator: Fresubin Original||
Dietary Supplement: Fresubin Original
|Experimental: Intestamin plus Fresubin Original||
Dietary Supplement: Intestamin plus Fresubin Original
- Length of stay in ICU [ Time Frame: 14 days ]The primary endpoints were length of stay in ICU and sufficient enteral feed.
- mortality [ Time Frame: 14 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167075
|Medical School Hannover|
|Hannover, Niedersachsen, Germany, 30625|