Trials / Completed
CompletedNCT04961866
Effects of Parenteral Protein Concentrations in Critically Ill Patients
Effects of Parenteral Protein Concentrations in Critically Ill Patients in Icu (Comparative Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Minia University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | parenteral protein 1 g/kg | patients received 1 g/ kg of protein |
| DIETARY_SUPPLEMENT | Parenteral nutrition 2 g/kg | Patients received 2 g/ kg of protein |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2021-03-01
- Completion
- 2021-03-01
- First posted
- 2021-07-14
- Last updated
- 2021-08-10
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04961866. Inclusion in this directory is not an endorsement.