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.: PACTR201907570828748 Date of Approval: 05/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Oral nutritional supplements for cirrhotic patients undergoing liver resection assessed by ultrasound measurement of Rectus Femoris and Anterior Tibialis muscles.
Official scientific title Oral nutritional supplements for cirrhotic patients undergoing liver resection assessed by ultrasound measurement of Rectus Femoris and Anterior Tibialis muscles.
Brief summary describing the background and objectives of the trial Malnutrition in patients with chronic liver disease results from a variable combination of inadequate intake, poor quality diet, altered macronutrient metabolism, maldigestion, malabsorption, , and hypermetabolic state (1,2). Malnutrition is an important prognostic factor. It is a challenge to manage nutrition in cirrhotic patients because of alterations to metabolic and storage functions of the liver. Patients with liver diseases, especially decompensated cirrhosis, commonly have weight loss and muscle wasting often have protein energy malnutrition (PEM), these conditions often result in sarcopenia, which is the loss of skeletal muscle volume and increased muscle weakness. In chronic liver disease severe protein-calorie malnutrition can seriously damaging the capacity of liver regeneration after liver resection surgeries, however nutritional support can improve the postoperative outcome (3) . In this prospective clinical study, we will evaluate the influence and adequate period for implementing of perioperative ONS for cirrhotic patients undergoing liver resection assessed by ultrasound measurement of quantitative and qualitative changes of rectus femoris and Vastus intermedius muscles over the course of the ICU . Secondary its impact on liver function, infectious complication and outcome. Patients .
Type of trial CCT
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 Diagnosis / Prognosis
Anticipated trial start date 01/04/2019
Actual trial start date 01/04/2019
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Active, not recruiting
Publication URL 00156/2019
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control receive conventional diet.patients will take a sip of water (SOW) at postoperative POD 0 and soft blended diet (SBD) at POD1 and then after all day of ICU admission receive conventional diet (CD group) . patients will take a sip of water (SOW) at postoperative POD 0 and soft blended diet (SBD) at POD1 and then after 20 Placebo
Experimental Group ONS.oral nutritio supplement group The target end point for ONS will be (35-40 kcal/kg and 1.2-1.5 g/kg of protein per day. It has been recommended that carbohydrates account for 45%-65% of caloric intake based on the dietary reference intake. postoperative ICU days ONS feeding will be start as 1.5 kcal/mL will give at a slow continuous rate, 10 mL/ hour over 24 hours. The rate will be increase (by 10 mL/h/d) until it reached 50 mL/h with care to avoid diarrhea and other complications. Meals and snacks incorporated every 3- 4 hours. A nighttime snack including at least 50 grams of carbohydrates . The target end point for ONS will be (35-40 kcal/kg and 1.2-1.5 g/kg of protein per day. It has been recommended that carbohydrates account for 45%-65% of caloric intake based on the dietary reference intake. A commercially available oral enteral nutrition will be given (nutritional drink supplements ,Fresenius kabi 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
hepatic patients classified as child A, B undergoing liver resection operation), with no past history of nutritional problems chronic use of drugs, orthopedic issues such as skeletal fractures or immobilization Refusal of the patient to share in the study, relevant comorbidities (renal, heart disease or COPD), previous immune abnormalities including treatment with corticosteroids, neuromuscular diseases, laparoscopic surgery. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 60 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 01/03/2019 INSTITUTION REVIEW BOARD OF THE NATIONAL LIVER INSTITUTE MENOUFIA UNIVERSITY
Ethics Committee Address
Street address City Postal code Country
YASSIN ABDEL GHAFAR menofia 048123 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cross sectional area of rectus femoris and Vastus intermedius muscles over the course of the ICU ICU STAY UP TO 7 DAY
Secondary Outcome ultrasound measurement of quantitative and qualitative changes of rectus femoris and Vastus intermedius muscles over the course of the ICU . and its impact on liver function, infectious complication and outcome. Inclusion criteria ICU STAY UP TO 7 DAY
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassin abdelghafar street menoufia 0481234 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen abdelghafar menofiya 048123 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National liver institute yassin abdel ghafar menofia 048123 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eman sayed emansayed825@gmail.com 002701282271464 5 abdelah esmaeil nasser elthawara
City Postal code Country Position/Affiliation
giza 1234 Egypt MD
Role Name Email Phone Street address
Scientific Enquiries GASSER ELAZAB g-elazb@l.ver.menofia.edu.eg 01289663992 menofeya
City Postal code Country Position/Affiliation
shebin elkom 048123 Egypt MD
Role Name Email Phone Street address
Public Enquiries HESHAM MAGED heshammaged@yahoo.com 002701223548537 haram ahmed ez
City Postal code Country Position/Affiliation
GIZA 1234 Egypt MD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will IPD sharing through PubMed Study Protocol we will IPD sharing through any journal PubMed cited we will use SPSS for statistical analysis after end fron collect the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
pubmed 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
Changes to trial information