Nutrition supplement for tube feeding assessed in hospitalized (ICU Stay) patients

Recruiting

• Conditions: Contact with and (suspected) exposure to unspecified communicable disease,

• Registration Number: CTRI/2022/12/047818
• Lead Sponsor: Dr Reddys Laboratories

Brief Summary

This study is a prospective open label, single arm, multicenter, interventional, study to assess the efficacy and tolerability of early enteral nutrition in hospitalized patients at participating centers aged in between 18 to 75 years in about 40 adult patients that will be conducted in India. The primary objectives is to study the impact of tube feeding supplement (Early enteral nutrition formula) for achieving the target Macro Nutrients levels and the number of days required to reach the target Macro Nutrients levels in hospitalized patients who are hemodynamically stabilized and requiring Enteral feeding for minimum 3 days. A total of 40 adult patients admitted to hospital will be enrolled for the study across different centers in India. Ease of achieving desired target, no. of days required to achieve the target and no. of days of hospital stay from Day 1 till Day 14th will be assessed in the study endpoints.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-12
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. To study the impact of tube feeding supplement for achieving the target Macro Nutrients levels 2) To study the number of days required to reach the target Macro Nutrients levels.

Exclusion Criteria

• 1. To study the impact of EN supplement on total protein, micronutrient levels such as Zn, Vitamin C, Mg, potassium and Phosphorous.
• 2. To study the impact of tube feeding supplement events of abdominal pain, distension, vomiting and diarrhea after EN supplement 3) To assess the number and reasons of interruptions during the tube feeding and ease of titration of the formula 4) To assess the impact of tube feeding supplement on hematological parameters from baseline to the end of the study.
• 5. To evaluate the palatability of the formulation in patients shifted to ward’s, through oral supplementation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Ease of achieving desired target, no. of days required to achieve the target and no. of days of ICU stay.	Baseline Visit, Day 1, Day 2, Day 3, Day 4-8, Day 8-14, End of study assessment.

Secondary Outcome Measures

Name	Time	Method
1) Improved vital status	2) No Interruptions to feeding

Trial Locations

Locations (4)

Care Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Criticare Superspeciality Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

Imperial Multispeciality Hospitals; 🇮🇳 Pune, MAHARASHTRA, India

Krishna Institute of Medical Sciences; 🇮🇳 Hyderabad, TELANGANA, India

Care Hospital

🇮🇳Hyderabad, TELANGANA, India

Dr B Ravinder Reddy

Principal investigator

04068159831

drbravinderreddy@gmail.com