Effects of Parenteral Protein Concentrations in Critically Ill Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Effects of Parenteral Protein Concentrations in Critically Ill Patients in Icu (Comparative Study)

Conditions
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Hand Muscle Strain

Intervention / Treatment
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* Dietary Supplement: parenteral protein 1 g/kg
* Dietary Supplement: Parenteral nutrition 2 g/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>patients received 1 g/ kg of protein | Dietary Supplement: parenteral protein 1 g/kg<br>* patients received 1 g/ kg of protein<br>|
| Active Comparator: Group B<br>patients received 2 g/ kg of protein | Dietary Supplement: Parenteral nutrition 2 g/kg<br>* Patients received 2 g/ kg of protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand grip strength | hand grip strength using dynamometer | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasound guided muscle thickness | us guided biceps and forearm muscle thickness | 10 days | 
| nitrogen balances | Measurements | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein, parenteral, critical ill patient, ICU