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.: PACTR201807118984852 Date of Approval: 16/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Safety And Efficacy Of Adding Intravenous N-Acetyl Cysteine To Parenteral L-Alanyl L-Glutamine In Hospitalized Patients Undergoing Colon Surgeries
Official scientific title “Safety And Efficacy Of Adding Intravenous N-Acetyl Cysteine To Parenteral L-Alanyl L-Glutamine In Hospitalized Patients Undergoing Colon Surgeries: A Randomized Controlled Clinical Trial”
Brief summary describing the background and objectives of the trial Colonic surgeries play a pivotal role in the treatment of colonic diseases, either benign diseases such as diverticular disease, and inflammatory bowel disease, or malignant diseases such as colon cancer. Surgery is the major activator of systemic inflammatory response syndrome (SIRS) which is a clinical response to a stimulus either inflammatory or traumatic.SIRS represents 80% in surgical patients hospitalized in ICU NAC has anti- inflammatory effect through the inhibition of release of pro-inflammatory cytokine TNF-α.Therefore, adding antioxidants as NAC to Gln reinforces its effect in patients suffering from oxidative stress and inflammatory responses. This paper aims to study the efficacy of NAC addition to l- alanyl l- glutamine in patients undergoing colonic surgeries, beside observing the potential risk and evaluating the safety of this regimen.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/07/2015
Actual trial start date 30/07/2015
Anticipated date of last follow up 28/10/2016
Actual Last follow-up date 28/10/2016
Anticipated target sample size (number of participants) 63
Actual target sample size (number of participants) 60
Recruitment status Completed
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
Experimental Group N acetylcysteine received a loading dose of IV bolus of NAC (Hidonac ® zambon, S.P.A, Vicenza, Italy) (100 mg/kg dissolved in dextrose5%) infused over 15 minutes, followed by continuous infusion of 50mg/kg/day dissolved in dextrose 5% starting 1hr before induction of anesthesia [13], and continued for 48 hours after operation perioperative and continued for 48 hours after operation intravenous N acetyl cysteine 30
Control Group dextrose received equal volume of dextrose 5% administrated at the same rate and duration as in the study group as a placebo perioperative and continued for 48 hours dextrose 5% intravenous 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged between 18 and 80 years. Need for ICU admission after colonic surgery. Requirement of TPN for at least 5 days due to failure of or contraindication for enteral nutrition. Signing a written informed consent Patients with persistent hemodynamic instability (systolic blood pressure <80 mm Hg). Renal impairment, hepatic insufficiency. Severe or uncontrolled sepsis Persistent metabolic acidosis. Head trauma, heart failure, Any sensitivity to components of L-alanyl L-glutamine (Dipeptiven®, Fresenius Kabi, Germany) or NAC Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 80 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 11/06/2015 Ain Shams University.
Ethics Committee Address
Street address City Postal code Country
Beside Ain Shams University, El Abbasia - Cairo - Egypt cairo 11588 11588 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome -evaluate the efficacy of NAC through assessing the changes in the serum level of malondialdehyde (MDA) as antioxidant marker 2 days after surgery
Primary Outcome evaluate changes in the tumor necrosis factor alpha (TNF-α) as anti-inflammatory marker 2 days after surgery
Secondary Outcome safety evaluation by recording any side effect that may appear from the study beginning till the patient discharge from the hospital.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams specialized hospital Beside Ain Shams University, El Abbasia cairo 11588 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ain shams universty elabbasya cairo 1156 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ghada eladly ghada_hussein97@yahoo.com +0201121717303 elzeitoun selim street
City Postal code Country Position/Affiliation
cairo 11724 Egypt clinical pharmacist in ain shams hospital
Role Name Email Phone Street address
Public Enquiries dina hussein dina_hussein05@yahoo.com +0201121717315 elzeitoun
City Postal code Country Position/Affiliation
cairo 1156 Egypt pharmacist in elkasr elainy
Role Name Email Phone Street address
Scientific Enquiries ahmed elgazar tropicalstorm82@yahoo.com +020100403500 shoubra
City Postal code Country Position/Affiliation
cairo 11724 Egypt lecturer at ain shams universty tropical medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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
Changes to trial information