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A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin) (Intestamin)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167075
First Posted: July 22, 2010
Last Update Posted: July 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fresenius Kabi
Information provided by:
Hannover Medical School
  Purpose
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.

Condition Intervention
Critical Illness Adult Sepsis Systemic Inflammatory Response Syndrome Dietary Supplement: Fresubin Original Dietary Supplement: Intestamin plus Fresubin Original

Study Type: Interventional
Study Design: Allocation: Randomized
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)

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Length of stay in ICU [ Time Frame: 14 days ]
    The primary endpoints were length of stay in ICU and sufficient enteral feed.


Secondary Outcome Measures:
  • 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.


Enrollment: 58
Study Start Date: February 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fresubin Original Dietary Supplement: Fresubin Original
Experimental: Intestamin plus Fresubin Original Dietary Supplement: Intestamin plus Fresubin Original

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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Germany
Medical School Hannover
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Fresenius Kabi
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Schneider, Andrea MD, Medical School Hannover
ClinicalTrials.gov Identifier: NCT01167075     History of Changes
Other Study ID Numbers: 3941
First Submitted: July 21, 2010
First Posted: July 22, 2010
Last Update Posted: July 22, 2010
Last Verified: December 2005

Keywords provided by Hannover Medical School:
critically ill
sepsis
antioxidants
enteral nutrition
SIRS (APACHE score 10-30)
enteral feeding within 48 h of admission

Additional relevant MeSH terms:
Sepsis
Critical Illness
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Disease Attributes
Shock