Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT04961866
Brief Summary:
Sixty patients who need Parenteral nutrition for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.
Detailed Description:
In this study after obtaining approval from our hospital ethics committee, a written informed consent will be obtained from patient's next of kin.
Sixty patients who need PN for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.
Inclusion criteria:
Age: from 18 to 60 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for\> 48 hs.
Exclusion criteria:
Pregnant female Hepatic patients Renal patients Age \<18 years
Technique of the study :
60 abdominal surgery/trauma ICU patients who have a contraindication or intolerance to enteral nutrition(EN),will be fed parenterally within 24-48 h from admission and divided according to the protein delivery into two groups.
Group A , those patients will receive parenteral proteins in a dose of 1 g/kg/day.
Group B, those patients will receive parenteral proteins in a dose of 2g/kg /day The nutrition will be delivered through a central line and using separate bottles technique ,because of the lack of a compounding unit and commercial bags in our hospital, After exclusion of the protein calories (will be given as 10%aa )the rest of energy requirement will be divided between carbohydrates (glucose25%)and lipids(SMOF20%) in a ratio of 60:40 Serum electrolytes, blood glucose, lipid profile and serum creatinine will be monitored and corrected regularly in every patient
The two groups will be compared as regarding the following :
hand grip strength Time of staying on Icu Time of staying in hospital Ultrasound biceps muscle thickness Nitrogen balances
Study:
NCT04961866
Study Brief:
Protocol Section:
NCT04961866