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

This study has been completed.
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01167075
First received: July 21, 2010
Last updated: NA
Last verified: December 2005
History: No changes posted
  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
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)

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167075

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

No publications provided by Hannover Medical School

Additional 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
Study First Received: July 21, 2010
Last Updated: July 21, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Critical Illness
Sepsis
Systemic Inflammatory Response Syndrome
Disease Attributes
Pathologic Processes
Infection
Inflammation
Shock

ClinicalTrials.gov processed this record on July 29, 2014