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

Not Applicable

Completed

• Conditions: Critical Illness; Adult; Sepsis; Systemic Inflammatory Response Syndrome
• Interventions: Dietary Supplement: Fresubin Original; Dietary Supplement: Intestamin plus Fresubin Original

• Registration Number: NCT01167075
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Status Verified: 2005-12
• Study Start: 2006-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-21
• Last Update Submitted: 2010-07-21
• Study First Posted: 2010-07-22
• Last Update Posted: 2010-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fresubin Original	Fresubin Original	-
Intestamin plus Fresubin Original	Intestamin plus Fresubin Original	-

Primary Outcome Measures

Name	Time	Method
Length of stay in ICU	14 days	The primary endpoints were length of stay in ICU and sufficient enteral feed.

Secondary Outcome Measures

Name	Time	Method
mortality	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.

Trial Locations

Locations (1)

Medical School Hannover; 🇩🇪 Hannover, Niedersachsen, Germany