The aim of this study is determining whether the restricted use of normal saline during anesthesia reduce the need for NaHCO3. In this study, seventy five patients with end-stage liver disease who will undergo OLT from Feb 2013 to December 2013 in the Shiraz organ transplantation center will be enrolled and fluid managements of two different transplant anesthetics will be compared. The effect of restricted normal saline fluid will be compared with non restricted normal saline fluid on hemodynamic and acid-base parameters at three times during OLT: 30 minutes after the skin incision (T1), 15 minutes before reperfusion (T2), and 5 minutes after reperfusion (T3).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110711662N5
Registration date:2013-11-24, 1392/09/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-24, 1392/09/03
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-02-01, 1391/11/13
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Intraoperative Restricted Normal Saline during Orthotopic Liver Transplantation on Amount of Administered Sodium Bicarbonate
Public title
The effect of restricted normal saline on the volume of sodium bicarbonate use during liver transplantation.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All adult patients with end-stage liver disease aged 16 and more,who will be underwent orthotropic deceased donor liver transplantation.
Exclusion criteria:patients with hepatorenal syndrome type І& ІІ; baseline serum potassium more than 6 meq/l; hepatopulmonary syndrome; portopulmonary hypertension; cardiac ejection fraction less than 60%; cirrhotic cardiomyopathy.
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University Medical Research Ethic Committee
Street address
Shiraz University of Medical Sciences ,Zand Blv
City
Shiraz
Postal code
197871345
Approval date
2013-11-09, 1392/08/18
Ethics committee reference number
CT-2013-170
Health conditions studied
1
Description of health condition studied
Liver Transplantation
ICD-10 code
Y83.0
ICD-10 code description
Surgical operation with transplant of whole organ
Primary outcomes
1
Description
was sodium bicarbonate dosage that will used during surgery
Timepoint
At the end of hepatectomy phase
Method of measurement
According to usage volume (ml)
Secondary outcomes
1
Description
Heart rate.
Timepoint
30 minutes after surgical incision,at start of anhepatic phase,at start of neohepatic phase.
Method of measurement
By electrocardiogram.
2
Description
Mean arterial blood pressure.
Timepoint
30 minutes after surgical incision,at start of anhepatic phase,at start of neohepatic phase.
Method of measurement
By arterial catheter in radial artery(mmHg)
3
Description
Central venous pressure
Timepoint
30 minutes after surgical incision,at start of anhepatic phase,at start of neohepatic phase
Method of measurement
By internal jagular catheter
Intervention groups
1
Description
In the restricted fluid group. patients received 5 ml/kg/hr crystalloid fluid during anesthesia for orthotopic liver transplantation
Category
N/A
2
Description
In the non restricted fluid group, patients received 10ml/kg/hr crystalloid fluid during anesrthesia for orthotopic liver transplantation
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital Organ Transplantation Center
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Namazi Hospital, Namazi Sq
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Shiraz University Of Medical Sciences building,Zand Blv
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq.
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
MohammadAli Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)