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.: PACTR201405000821398 Date of Approval: 07/05/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title evaluating inflammatory response in ICU patients requiring TPN using SMOF lipd 20% versus Intralipid 20%
Official scientific title evaluating inflammatory response in ICU patients requiring TPN using SMOF lipd 20% versus Intralipid 20%
Brief summary describing the background and objectives of the trial patients presenting for major abdominal surgery requiring at least 5 day TPN to assess inflammaltory response using SMOF lipid versus intralipid.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative abdominal surgery patients,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2014
Actual trial start date 07/06/2014
Anticipated date of last follow up 07/08/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
assessing liver enzymes, and coagulopathy Medical research institute
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 a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMOF intralipid 1.5 g/kg/day 5 days at least iv infusion of SMOF intralipid 20% 25
Experimental Group Intralipid 1.5 g/kg/day 5 days at least iv infusion of intralipid 20% 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
postoperative major abdominal surgical patients requiring at least 5 day total parenteral nutrition patients need TPN for less than 5 days non abdominal surgery allergy to any of the components of the lipid mixture 30 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
No 01/06/2014 Medical Research Institute ethical committee
Ethics Committee Address
Street address City Postal code Country
165 Horreya street -Alhadara Alexandria 21556 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome impact of either mixture on inflammatory response daily measuring : Il6 , TNF alpha
Secondary Outcome liver enzyme and coagulopathy daily measuring: Alt, Ast, coagulation tests,and blood count
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
medical research institute 165 horreya street-Ahadara Alexandria 21556 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Institute 165 horreya street-Ahadara Alexandria 21556 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute 165 horreya street-Ahadara Alexandria 21556 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Medical Research Institute 165 horreya street-Ahadara Alexandria 21556 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Ahmed Abdelhamid dr_shereif@hotmail.com 002/01001459756 165 horreya road-Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt doctor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries mohamed ellakany melakany@yahoo.com 00201001459756 165 horreya road-Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt doctor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Ashraf Arafat dr_shereif@hotmail.com 002/01001459756 165 horreya road-Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Assitant professor of anesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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