Effects of Parenteral Protein Concentrations in Critically Ill Patients in Icu (Comparative Study)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Minia University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- hand grip strength
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: from 18 to 70 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for\> 48 hs.
Exclusion Criteria
- •Hepatic patients Renal patients Age \<18 years
Outcomes
Primary Outcomes
hand grip strength
Time Frame: 10 days
hand grip strength using dynamometer
Secondary Outcomes
- nitrogen balances(10 days)
- ultrasound guided muscle thickness(10 days)
Investigators
Karim Naser Hasan
assisstant lecturer
Minia University