A Randomized, Prospective, Controlled, Double-blind, Single-center Pilot Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hannover Medical School
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Length of stay in ICU
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intestamin plus Fresubin Original
Intervention: Intestamin plus Fresubin Original (Dietary Supplement)
Fresubin Original
Intervention: Fresubin Original (Dietary Supplement)
Outcomes
Primary Outcomes
Length of stay in ICU
Time Frame: 14 days
The primary endpoints were length of stay in ICU and sufficient enteral feed.
Secondary Outcomes
- mortality(14 days)