Clinical trial NCT01167075: A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Adult
Sepsis
Systemic Inflammatory Response Syndrome
Keywords: critically ill
sepsis
antioxidants
enteral nutrition
SIRS (APACHE score 10-30)
enteral feeding within 48 h of admission
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Fresenius Kabi
First posted: 2010-07-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of stay in ICU
timeFrame: 14 days
Secondary outcomes:
measure: mortality
timeFrame: 14 days
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover
state: Niedersachsen
Study officials:
References:
citation: Schneider A, Markowski A, Momma M, Seipt C, Luettig B, Hadem J, Wilhelmi M, Manns MP, Wedemeyer J. Tolerability and efficacy of a low-volume enteral supplement containing key nutrients in the critically ill. Clin Nutr. 2011 Oct;30(5):599-603. doi: 10.1016/j.clnu.2011.04.003. Epub 2011 May 31.