Effects of Parenteral Protein Concentrations in Critically Ill Patients
Primary Purpose
Hand Muscle Strain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
parenteral protein 1 g/kg
Parenteral nutrition 2 g/kg
Sponsored by
About this trial
This is an interventional supportive care trial for Hand Muscle Strain focused on measuring protein, parenteral, critical ill patient, ICU
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
Sites / Locations
- Karim Naser Hasan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
patients received 1 g/ kg of protein
patients received 2 g/ kg of protein
Outcomes
Primary Outcome Measures
hand grip strength
hand grip strength using dynamometer
Secondary Outcome Measures
ultrasound guided muscle thickness
us guided biceps and forearm muscle thickness
nitrogen balances
Measurements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961866
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Muscle Strain
Keywords
protein, parenteral, critical ill patient, ICU
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
patients received 1 g/ kg of protein
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
patients received 2 g/ kg of protein
Intervention Type
Dietary Supplement
Intervention Name(s)
parenteral protein 1 g/kg
Intervention Description
patients received 1 g/ kg of protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Parenteral nutrition 2 g/kg
Intervention Description
Patients received 2 g/ kg of protein
Primary Outcome Measure Information:
Title
hand grip strength
Description
hand grip strength using dynamometer
Time Frame
10 days
Secondary Outcome Measure Information:
Title
ultrasound guided muscle thickness
Description
us guided biceps and forearm muscle thickness
Time Frame
10 days
Title
nitrogen balances
Description
Measurements
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim A. Youssif, MD
Organizational Affiliation
Minia University
Official's Role
Study Chair
Facility Information:
Facility Name
Karim Naser Hasan
City
Minya
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Parenteral Protein Concentrations in Critically Ill Patients
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