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OpenTrials
Completed

NCT Number: NCT04961866

Effects of Parenteral Protein Concentrations in Critically Ill Patients

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karim Naser Hasan

Minya, 61111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parenteral protein 1 g/kg

Dietary Supplement

patients received 1 g/ kg of protein

Parenteral nutrition 2 g/kg

Dietary Supplement

Patients received 2 g/ kg of protein

Primary outcomes

  1. hand grip strength

    Time frame: 10 days

    hand grip strength using dynamometer

Secondary outcomes

  1. ultrasound guided muscle thickness

    Time frame: 10 days

    us guided biceps and forearm muscle thickness

  2. nitrogen balances

    Time frame: 10 days

    Measurements

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2021
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.