Restricted Crystalloid fluid Therapy during Liver Transplant Surgery and Its Effect on Pulmonary and Renal insufficiency in the Early postoperative period. A randomized clinical trial
The aim of the present study is evaluation of the relation between intra-operative fluid therapy and early renal and pulmonary complications after liver transplantation. Sixty three patients with end-stage liver disease (ESLD) that undergoing orthotopic deceased donor liver transplantation will be enrolled .They will be randomly divided into two groups including restricted fluid group which will receive a controlled fluid administration of normal saline (5mg/kg/hr during anaesthesia) and non restricted fluid group will receive a continuous controlled infusion of isotonic saline (10ml/kg/hr during anesthesia). Early postoperative pulmonary and renal complications in both groups will be assessed and compared with each other. The patients will be monitored during the three stages of liver transplantation through hemodynamic parameters assessment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013101811662N4
Registration date:2013-11-11, 1392/08/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-11, 1392/08/20
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
Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences .
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Restricted Crystalloid fluid Therapy during Liver Transplant Surgery and Its Effect on Pulmonary and Renal insufficiency in the Early postoperative period. A randomized clinical trial
Public title
The effect of restricted fluid therapy on posoperative renal and pulmonary complications following liver transplantation.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Eligible participants are all adult patients with end-stage liver who will candidate for liver transplantation.
Exclusion criteria: The patients with history of Asthma; chronic obstructive lung disease; hepatopulmonary syndrome; hepatopulmonary hypertension; hepatorenal syndrome; renal failure.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
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
2013-10-06, 1392/07/14
Ethics committee reference number
CT-2013-165
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
Incidece of acute renal failure
Timepoint
1st day postoperation, 2nd day post operation, 3rd day postoperation.
Method of measurement
Acute renal failure is define according to serum creatinine.
2
Description
Incidence of acute respiratory failure
Timepoint
1st day postoperation, 2nd day post operation, 3rd day postoperation.
Method of measurement
By doiing arterial blood gas.
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
Cardiac output.
Timepoint
30 minutes after surgical incision,at start of anhepatic phase,at start of neohepatic phase.
Method of measurement
By NICO system for measuring noninvasive CO.
4
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
Treatment - Other
2
Description
In the non restricted fluid group, patients received 10ml/kg/hr crystalloid fluid during anesrthesia for orthotopic liver transplantation
Category
Treatment - Other
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 Anesthesilology 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
+98 711
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)