A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
Intestamin
A Randomized, Prospective, Controlled, Double-blind, Single-center Pilot Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedJuly 22, 2010
December 1, 2005
3 years
July 21, 2010
July 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of stay in ICU
The primary endpoints were length of stay in ICU and sufficient enteral feed.
14 days
Secondary Outcomes (1)
mortality
14 days
Study Arms (2)
Fresubin Original
ACTIVE COMPARATORIntestamin plus Fresubin Original
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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. -
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hannover Medical Schoollead
- Fresenius Kabicollaborator
Study Sites (1)
Medical School Hannover
Hanover, Lower Saxony, 30625, Germany
Related Publications (1)
Schneider A, Markowski A, Momma M, Seipt C, Luettig B, Hadem J, Wilhelmi M, Manns MP, Wedemeyer J. Tolerability and efficacy of a low-volume enteral supplement containing key nutrients in the critically ill. Clin Nutr. 2011 Oct;30(5):599-603. doi: 10.1016/j.clnu.2011.04.003. Epub 2011 May 31.
PMID: 21621886DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 21, 2010
First Posted
July 22, 2010
Study Start
February 1, 2006
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
July 22, 2010
Record last verified: 2005-12