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Effects of Parenteral Protein Concentrations in Critically Ill Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04961866
Enrollment
60
Registered
2021-07-14
Start date
2020-01-01
Completion date
2021-03-01
Last updated
2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Muscle Strain

Keywords

protein, parenteral, critical ill patient, ICU

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

Interventions

DIETARY_SUPPLEMENTparenteral protein 1 g/kg

patients received 1 g/ kg of protein

DIETARY_SUPPLEMENTParenteral nutrition 2 g/kg

Patients received 2 g/ kg of protein

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
hand grip strength10 dayshand grip strength using dynamometer

Secondary

MeasureTime frameDescription
ultrasound guided muscle thickness10 daysus guided biceps and forearm muscle thickness
nitrogen balances10 daysMeasurements

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026