Effects of Parenteral Protein Concentrations in Critically Ill Patients

Minia University

Status: Completed

Conditions: Hand Muscle Strain

Treatments: Dietary Supplement: Parenteral nutrition 2 g/kg; Dietary Supplement: parenteral protein 1 g/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT04961866

308:10/2019

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group A

Active Comparator group

Description:

patients received 1 g/ kg of protein

Treatment:

Dietary Supplement: parenteral protein 1 g/kg

Group B

Active Comparator group

Description:

patients received 2 g/ kg of protein

Treatment:

Dietary Supplement: Parenteral nutrition 2 g/kg