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

Primary Purpose

Critical Illness, Adult, Sepsis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fresubin Original
Intestamin plus Fresubin Original
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring critically ill, sepsis, antioxidants, enteral nutrition, SIRS (APACHE score 10-30), enteral feeding within 48 h of admission

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical School Hannover

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fresubin Original

Intestamin plus Fresubin Original

Arm Description

Outcomes

Primary Outcome Measures

Length of stay in ICU
The primary endpoints were length of stay in ICU and sufficient enteral feed.

Secondary Outcome Measures

mortality
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.

Full Information

First Posted
July 21, 2010
Last Updated
July 21, 2010
Sponsor
Hannover Medical School
Collaborators
Fresenius Kabi
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1. Study Identification

Unique Protocol Identification Number
NCT01167075
Brief Title
A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
Acronym
Intestamin
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 Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School
Collaborators
Fresenius Kabi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Adult, Sepsis, Systemic Inflammatory Response Syndrome
Keywords
critically ill, sepsis, antioxidants, enteral nutrition, SIRS (APACHE score 10-30), enteral feeding within 48 h of admission

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fresubin Original
Arm Type
Active Comparator
Arm Title
Intestamin plus Fresubin Original
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Fresubin Original
Intervention Type
Dietary Supplement
Intervention Name(s)
Intestamin plus Fresubin Original
Primary Outcome Measure Information:
Title
Length of stay in ICU
Description
The primary endpoints were length of stay in ICU and sufficient enteral feed.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
mortality
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical School Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21621886
Citation
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.
Results Reference
derived

Learn more about this trial

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

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