To assess the efficacy, safety and tolerability of CELNUTRA 2.0 and Kitchen feed in the Intensive Care Unit Patients
- Conditions
- Health Condition 1: E640- Sequelae of protein-calorie malnutrition
- Registration Number
- CTRI/2023/05/052938
- Lead Sponsor
- ucgenex lifesciences Pvt. Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. All patients who are admitted to the intensive care unit (ICU) including gastrointestinal incompliant subjects who need enteral tube feeding along with other nourishment.
2. Patients >=18 years old subjects where enteral nutrition is begun by the attending physician during the first 48 hours, and are expected to require nutritional support for 1 week or more.
3. Patients whose NUTRIC score and body composition is analyzed at admission and at discharge using the bioelectrical impedance analysis (BIA).
4. Patients legally acceptable representative provide informed consent for collection of patients information for research purpose.
1. Pregnant and breast-feeding women
2. Multiorgan failure
3. Not expected to survive due to the severity of their illness or traumatic injuries
4. Short bowel syndrome
5. Enterocutaneous fistula
6. Intestinal ischemia
7. Massive gastrointestinal haemorrhage
8. Gastrointestinal resection
9. Given parenteral nutrition
10. The patient is acutely impacted or constipated, or has intestinal obstruction
11. Had severe intolerance for enteral nutrition or formula
12. The patient has an allergy or intolerance to any ingredient in the study product
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective Global Assessment Form (SGA)Timepoint: Baseline (Day 0), 3 days, 5 days, 7 days, 10 days, 14 days, on the day of discharge and 28 days
- Secondary Outcome Measures
Name Time Method Body composition analyzerTimepoint: Baseline (Day 0), 3 days, 5 days, 7 days, 10 days, 14 days, on the day of discharge and 28 days;Dietary intake (increased or reduced)Timepoint: Baseline (Day 0), 3 days, 5 days, 7 days, 10 days, 14 days, on the day of discharge and 28 days;Enteral protein intakeTimepoint: Baseline (Day 0), 3 days, 5 days, 7 days, 10 days, 14 days, on the day of discharge and 28 days;Fluid accumulationTimepoint: Baseline (Day 0), 3 days, 5 days, 7 days, 10 days, 14 days, on the day of discharge and 28 days;Nutrition Risk in the Critically Ill (NUTRIC) ScoreTimepoint: Baseline (Day 0), 3 days, 5 days, 7 days, 10 days, 14 days, on the day of discharge and 28 days;Safety and tolerance -Gastrointestinal toleranceTimepoint: Baseline (Day 0), 3 days, 5 days, 7 days, 10 days, 14 days, on the day of discharge and 28 days