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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
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
June 28, 2021
Last Updated
August 3, 2021
Sponsor
Minia University
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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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