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

A Randomized, Prospective, Controlled, Double-blind, Single-center Pilot Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01167075

Acronym

Intestamin

Enrollment

Registered

2010-07-22

Start date

2006-02-28

Completion date

2009-02-28

Last updated

2010-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult, Critical Illness, Sepsis, Systemic Inflammatory Response Syndrome

Keywords

critically ill, sepsis, antioxidants, enteral nutrition, SIRS (APACHE score 10-30), enteral feeding within 48 h of admission

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.

Interventions

DIETARY_SUPPLEMENTFresubin Original

DIETARY_SUPPLEMENTIntestamin plus Fresubin Original

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Length of stay in ICU	14 days	The primary endpoints were length of stay in ICU and sufficient enteral feed.

Secondary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026