Status:
COMPLETED
A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Fresenius Kabi
Conditions:
Critical Illness
Adult
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
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 affec...
Eligibility Criteria
Inclusion
- sepsis or SIRS (APACHE score 10-30),
- no severe gastrointestinal tract or metabolic diseases,
- enteral feeding within 48 h of admission,
- age 18-75 years,
- written consent by patient or next of kin. -
Exclusion
- participation in a drug trial within the last 4 weeks before inclusion in this study,
- previous participation in this study,
- expected patient survival of less than 6 days,
- pregnancy or lactation,
- patients with unstable vital signs that would probably cause incidents that would make participation impossible or would lead to discontinuation,
- severe liver disease with cytolysis (ASAT \>10 N) or impaired detoxification (ammonia \>50 mmol/L, bilirubin \> 50 μmol/L),
- gastrointestinal surgery in the last 4 weeks,
- severe enteritis/colitis,
- short intestine syndrome,
- gastrointestinal bleeding that requires intervention,
- patients who could not be enterally fed
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01167075
Start Date
February 1 2006
End Date
February 1 2009
Last Update
July 22 2010
Active Locations (1)
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1
Medical School Hannover
Hanover, Lower Saxony, Germany, 30625