The comparison of effect of Mannitol infusion and N Acettyl Cysteine on liver function in patients undergoing partial hepathectomy
Design
The trial is functional, randomised two arm parallel groups, double blinded post op care and outcome assessment.
Settings and conduct
The trial has been done in Golestan Hospital, Ahvaz University of Medical Science. The surgeon, the patient and the assesor were kept blind of the used medication. The randomization method of using medicine was done alternatively, starting with Mannitol infusion for first patient and went on.
Participants/Inclusion and exclusion criteria
ASA class 1 & ASA class 2, Age between 16 to 60, No mortal disease, CHILD-POUGH Score 1
Intervention groups
Two different groups of patients with 6 participants suffering from liver disease who have been candidate for partial hepatectomy surgery, were chosen randomly and a specific medication was used for each group.
Main outcome variables
Liver enzymes; coagulation profile; acid base pofile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180221038809N1
Registration date:2018-05-15, 1397/02/25
Registration timing:retrospective
Last update:2018-05-15, 1397/02/25
Update count:0
Registration date
2018-05-15, 1397/02/25
Registrant information
Name
Masuomeh Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3232 4568
Email address
alizadeh.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2018-05-10, 1397/02/20
Actual recruitment start date
2018-03-16, 1396/12/25
Actual recruitment end date
2018-05-15, 1397/02/25
Trial completion date
empty
Scientific title
The comparison of effect of Mannitol infusion and N Acettyl Cysteine on liver function in patients undergoing partial hepathectomy
Public title
The effect of N_Acettyl cysteine on hepatectomy outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age
ASA class1 & ASA class 2
No mortal clinical illness
Exclusion criteria:
ASA class 3 & ASA class 4
Sever coagulopathy
ESRD
Cirrhosis
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
12
Actual sample size reached:
12
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Healthcare provider and investigator are the same person. Outcome assessor is blind.
Placebo
Not used
Assignment
Parallel
Other design features
No special feature
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Ahvaz University of Medical Sciences
Lab data during operation, 6,12,24 hrs and 3 days after surgery
Method of measurement
IU/L for liver enzymes, (Mg/dl for PT, PTT, INR), PH For asidosis
Secondary outcomes
1
Description
Bun and Cr was checked.
Timepoint
Bun & Cr data were checked 6، 12 and 24 hrs after surgery
Method of measurement
Blood sampling
Intervention groups
1
Description
N acettyl cystein is an amino acid with a sulfur base and thiol. Drug is in form of 2gr/ ml vials and was injected by dose of 100mg/kg before hepatic artery clamping intraoperatively to group 1 pateints.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Univarsity of Medical Science, Golestan Hospital
Mr Mohammad Badavi office., Commite of research., University of Medicine., Jundishapoor University of Medical Science., Farvardin bolvard., Golestan., Ahvaz., Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
61357_15794
Email
badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?