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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Illness, Adult, Sepsis, Systemic Inflammatory Response Syndrome

Intervention / Treatment
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* Dietary Supplement: Fresubin Original
* Dietary Supplement: Intestamin plus Fresubin Original


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fresubin Original<br> | Dietary Supplement: Fresubin Original<br> <br> |
| Experimental: Intestamin plus Fresubin Original<br> | Dietary Supplement: Intestamin plus Fresubin Original<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critically ill, sepsis, antioxidants, enteral nutrition, SIRS (APACHE score 10-30), enteral feeding within 48 h of admission