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To assess the efficacy, safety and tolerability of CELNUTRA 2.0 and Kitchen feed in the Intensive Care Unit Patients

A Prospective, Multicenter, Open-Label, Single-Arm, prescription event monitoring, observational study to assess the efficacy, safety and tolerability of Enteral Feeding with High Protein, high-calorie and Semi-elemental Formula (CELNUTRA 2.0) and Kitchen feed in the Intensive Care Unit (ICU) Subjects (Protocol: CELNUTRA 2.0 - 01/2022; Version: 01, 01/07/2022)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/05/052938
Enrollment
70
Registered
2023-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E640- Sequelae of protein-calorie malnutrition

Interventions

Intervention1: CELNUTRA 2.0 - High Protein and high-calorie Semi-elemental Formula and Kitchen feed: The daily calorie and protein prescriptions were calculated from standard recommendations (calories

Sponsors

Nucgenex lifesciences Pvt. Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactMs Datta Patel

Department of Sports Sciences

datta.patel@dypatil.edu

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026