Health Condition 1: E898- Other postprocedural endocrine andmetabolic complications and disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ready to Sign informed consent form or informed consent form signed by legally acceptable representatives. 2.Aged more than 18 years 3.Gender: Male & Female. 4.Hospitalized patients requiring isocaloric formula for enteral feeding. 5.Can tolerate enteral tube feeding. 6.Estimated duration of Hospital stays equal to or greater than 2 days.
Exclusion criteria
Exclusion criteria: 1.Receiving tube feeding prior to hospitalization. 2.Patients less than 18 years of age. 3.Patients having allergy to constituents of Maxvida High Protein. 4.Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To study Continuous GI tolerance (Product Compliance): a. Diarrhea free day b. Stomach irritation c. Regurgitation d. Abdominal bloating e. Vomiting f. GRV less than 500 ml (GRV to be checked at 0730 hours, 0900 hours, 1530 hours, 1700 hours)Timepoint: end of hospitalization or 5 days whichever earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To Evaluate Change in weight (kg) during pre and post intervention of the study product 2.To Evaluate Change in serum albumin during pre and post intervention of the study product 3.Adverse event and serious adverse event monitoring based on clinical and laboratory AE’s.Timepoint: end of hospitalization or 5 days whichever earlier. | — |
Countries
India
Contacts
Mediception Science Pvt Ltd.