Clinical trial NCT04961866: Effects of Parenteral Protein Concentrations in Critically Ill Patients
Official title: Effects of Parenteral Protein Concentrations in Critically Ill Patients in Icu (Comparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Muscle Strain
Keywords: protein
parenteral
critical ill patient
ICU
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: hand grip strength
timeFrame: 10 days
Secondary outcomes:
measure: ultrasound guided muscle thickness
timeFrame: 10 days
measure: nitrogen balances
timeFrame: 10 days
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Karim Naser Hasan
Study officials:
affiliation: Minia University
name: Ibrahim A. Youssif, MD
role: STUDY_CHAIR
References: