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

Hannover Medical School (MHH)

Status: Completed

Conditions: Adult; Critical Illness; Systemic Inflammatory Response Syndrome; Sepsis

Treatments: Dietary Supplement: Fresubin Original; Dietary Supplement: Intestamin plus Fresubin Original

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01167075

3941

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Fresubin Original

Active Comparator group

Treatment:

Dietary Supplement: Fresubin Original

Intestamin plus Fresubin Original

Experimental group

Treatment:

Dietary Supplement: Intestamin plus Fresubin Original