Critical Illness, Infection Complication, Multiple Organ Dysfunction Syndrome
Conditions
Keywords
Colostrum, Critical Care Outcomes, Intensive Care Unit, Inflammation, Infection, mortality
Brief summary
Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids, selenium, and antioxidants has been suggested to reduce infections and improve recovery from critical illness. However, the effects of colostrum on clinical outcomes in critical ill patients has not been investigated. In current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.
Detailed description
A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. Intervention patients will be received 20 g/day of colostrum along with enteral formula and control patients will be received maltodextrin along with enteral formula. Patients will be assessed for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.
Interventions
DIETARY_SUPPLEMENTColostrum
Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
DIETARY_SUPPLEMENTMaltodextrin
Maltodextrin mixed with water given via NG tube Q 4 hours.
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years old) admitted to ICU * Start of study intervention within 48 hours after ICU admission * Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour * Written informed consent of patient or written informed consent of legal representative
Exclusion criteria
* Enrollment in a related ICU interventional study * Requiring other specific enteral nutrition for medical reason * Death or Discharge before 5th day * Having any contra-indication to receive enteral nutrition * Pregnant patients or lactating with the intent to breastfeed * BMI \<18 or \> 40.0 kg/m2 * Have life expectancy of \<6 mo * Patients who are moribund * History of allergy or intolerance to the study product components * Receiving colostrum during two weeks before start study product * Have other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of infection | Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| 28-day Mortality | Day 28 |
| 6-month mortality | month 6 |
| Length of stay in ICU | Day 28 |
| Serum Immunity Markers | baseline, Day 5, Day 10 |
| Serum Inflammatory Markers | baseline, Day 5, Day 10 |
Countries
Iran
Outcome results
None listed