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

Sepsis Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167075
• Other study ID #: 3941
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: July 21, 2010
• Start date: February 2006
• Est. completion date: February 2009

Study information

• Verified date: December 2005
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adult
• Critical Illness
• Sepsis
• Systemic Inflammatory Response Syndrome

Intervention

Dietary Supplement:
• Fresubin Original

• Intestamin plus Fresubin Original

Locations

Country	Name	City	State
Germany	Medical School Hannover	Hannover	Niedersachsen

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in ICU	The primary endpoints were length of stay in ICU and sufficient enteral feed.	14 days	No
Secondary	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.	14 days	No