Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006791593580 Date of Approval: 08/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Standard versus High Protein Enteral Feeding
Official scientific title Effect of Standard versus High Protein Enteral Feeding on Rectus Femoris Muscle Mass in Head Injury Patients: Prospective Randomized Study.
Brief summary describing the background and objectives of the trial Muscle wasting is a common finding in critically ill patients and is associated with adverse outcomes. A good strategy for avoidance or decreasing muscle loss is by adding adequate quantities of protein to the nutritional therapy administered during the acute phase of disease during ICU stay.The aim of this prospective randomized controlled study is to compare the effect of standard vs. high protein entral feeding on Rectus Femoris Muscle mass in head injury patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2019
Actual trial start date
Anticipated date of last follow up 01/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard formula group Patients in this group will receive protein at (1.5 gm/kg/day). ALONG TE COURSE OF ICU TSAY The caloric requirement for each patient will be detected by indirect calorimetry and will be supplied in the form of high caloric entral formula (1.5kcal/ml, 100ml contains 5.6 g protein) and the protein supplementation will be completed by the addition of enteral supplemental protein as required to reach the target level of protein (1.5 gm/kg/day). 40 Active-Treatment of Control Group
Experimental Group High protein formula group Patients in this group will receive protein (2.2 gm/kg/day). ALONG THE COURSE OF ICU STAY The caloric requirement for each patient will be detected by indirect calorimetry and will be supplied in the form of high caloric entral formula (1.5kcal/ml, 100ml contains 5.6 g protein) and the protein supplementation will be completed by the addition of enteral supplemental protein as required to reach the target level of protein (2.2 gm/kg/day). 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Adult Brain Trauma patients of both sexes Glasgow Coma Scale ≤ 8 and an injury severity score (ISS>15) who were admitted to our ICU within 24 hours after the injury. only well-nourished ( Modified Nutric –Score for Risk Screening = 0- 4) (10), previously healthy subjects will be recruited  Pregnancy,  Vascular insufficiency or trauma to the lower limbs,  History of neuromuscular diseases,  Prolonged immobility prior to ICU admission,  Comorbidities (renal, hepatic, cardiac disorders, chronic obstructive pulmonary disease, and diabetic patient),  Patients with BMI ≥ 35 ,  Patients with malignant diseases or immune disorders,  Prolonged corticosteroids (CS) and/ or neuromuscular blocking agents (NMBA) use ,  ARDS patient (P/F ratio ≤ 200),  Sepsis, Multiorgan failure. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/12/2018 Ethics committe of the Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
Elgeish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the percentage of reduction in the muscle mass measured by US. day 0 , 5 , 10, 15 and 20 of ICU admission
Secondary Outcome -Pennation angle, cross sectional area, and Echogenicity of rectus femoris muscle, day 0 , 5 , 10, 15 and 20 of ICU admission
Secondary Outcome Length of mechanical ventilation and ICU stay once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The intensive care unit of Tanta University Hospital Elgeish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Tanta University Elgeish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University Elgeish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Blough El Mourad Elgeish Tanta 31527 Egypt
Hanan ELSaied Mohamed ELKalawy Elgeish Tanta 31527 Egypt
Mohammad Ali Mohammad Abdullah Elgeish Tanta 31527 Egypt
Mohammed Alaa Elsaied Barrima Elgeish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanan ELKalawy hanan.elsaied@med.tanta.edu.eg 0020403332033 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt ASSISTANT LECTURER
Role Name Email Phone Street address
Public Enquiries Mona El Mourad mona.fayad@med.tanta.edu.eg 0020403332033 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Hanan ELKalawy hanan.elsaied@med.tanta.edu.eg 0020403332033 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1- Demographic data e.g. age, sex, weight body mass index (BMI), Modified Nutric score. 2- Quantitative parameters: Pennation angle, cross sectional area of rectus femoris muscle: at baseline then at day 5th, 10th, 15th &20th after initiation of nutritional therapy. 3- Qualitative parameter: Echogenicity by Heckmatt scale: at baseline then at day 5th, 10th, 15th &20th after initiation of nutritional therapy. 4- Length of mechanical ventilation and ICU stay will be estimated and compared in the two groups. Study Protocol 2years to those who request the data via the email of the principal investigator according to the cause of request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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