Health Condition 1: E63- Other nutritional deficiencies Health Condition 2: E638- Other specified nutritional deficiencies
Conditions
Interventions
Intervention1: Soluble Fiber Resistant Maltodextrin: 30 gm fiber / day
Study Period
Period of ICU Stay Minimum 3 Days Maximum 5 Days and With A Followup of 7 Days
Control Intervention1: No Fiber Suppl
Sponsors
Hexagon Nutrition Limited
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients more than 18 years of age Hemodynamically stable defined as no escalating high-dose vasopressors in last 24 hours Patients who are fed only on Scientific formulas Acutely admitted to the medical or surgical ICU Admitted to ICU and expected to require enteral tube feeding via for nasogastric tube more than or equal to 72 hours Informed Consent from the patient surrogate
Exclusion criteria
Exclusion criteria: Age below 18 years of age Contraindication to EN or PN Post organ Transplant Patients who are on Pharmacotherapeutic agents Laxatives Purgatives and Prokinetic agents Pregnancy and Lactating mothers Preexisting Inflammatory bowel disease Short bowel syndrome with high output fistula Bowel obstruction Ischemia Active GI bleed Infective diarrhea Chronic diarrhea GI motility GRV more than 500 ml despite prokinetics ileus chronic constipation Major GI surgery with contraindications to enteral fiber surgeon discretion Known allergy or intolerance to the enteral formulas or on blenderized feeds or on exclusive PN Limited life expectancy Participation in any clinical trial in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Resistant Maltodextrin soluble fiber specifically PentaSure Fiber as a prebiotic in ICU patients as an prophylactic treatment with the aim of minimizing GI disturbances and improving gut healthTimepoint: Within 24 to 48 hrs of Enteral Feed Day 1 Day 2 Day 3 Day 4 Day 5 Followup | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of soluble fiber in regulating blood sugar levels among critically ill patients To monitor enteral nutrition tolerance and nutritional adequacy calories protein delivered vs prescribed To assess the need for laxatives and anti diarrheal medicationsTimepoint: within 24 to 48 hrs of Enteral Feed Day 1 Day 2 Day 3 Day 4 Day 5 Followup | — |
Countries
India
Contacts
Public ContactDr Sunitha Premalatha
Hexagon Nutrition Ltd
Outcome results
None listed