Comparison of the Effects of Two Methods of Liberal and Restericted Fluid Therapy on Renal Function Indices in Gastric Bypass by Laparoscopic
Design
Single central, randomized, Single-blind, Phase 2 clinical trials. Seventy-seven candidates for gastric bypass surgery were assigned to a similar number in two groups under pre-operative restericted fluid therapy and pre-operative liberal fluid therapy.
Settings and conduct
Patients undergoing laparoscopic gastric Bypass surgery in Rasoul-e-Akram Hospital will be randomly assigned to pre-operative restericted fluid therapy and undergo pre-operative liberal fluid therapy. So that the patient does not know the patient's assigned group.
Participants/Inclusion and exclusion criteria
Inclusion criteria for study include: All patients undergoing gastric bypass surgery by Laparoscopic. Exclusion criteria for study include: age below 18 years, history of preoperative renal dysfunction, history of cardiovascular and pulmonary disease, and pregnancy.
Intervention groups
The first intervention group was placed under preoperative restericted fluid therapy and the second intervention group was placed under preoperative free-fluid therapy.
Main outcome variables
The main outcome is the serum BUN.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170109031852N3
Registration date:2019-08-07, 1398/05/16
Registration timing:registered_while_recruiting
Last update:2019-08-07, 1398/05/16
Update count:0
Registration date
2019-08-07, 1398/05/16
Registrant information
Name
Mahzad Alimian
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
alimian.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Two Methods of Liberal and Restericted Fluid Therapy on Renal Function Indices in Gastric Bypass by Laparoscopic
Public title
Effects of Liberal and Restericted Fluid Therapy on Renal Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria for study include: All patients undergoing gastric bypass surgery by Laparoscopic.
Exclusion criteria:
Exclusion criteria for study include: age below 18 years, history of preoperative renal dysfunction, history of cardiovascular and pulmonary disease, and pregnancy.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method will be used using a random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study were not informed about the prescribed treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9411174020
Health conditions studied
1
Description of health condition studied
Gastric Bypass
ICD-10 code
Y83.2
ICD-10 code description
Surgical operation with anastomosis, bypass or graft
Primary outcomes
1
Description
Serum BUN
Timepoint
Before and 24 hours after surgery
Method of measurement
Obtaining venous blood samples and laboratory techniques
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Under the restericted fluid treatment before surgery.
Category
Treatment - Drugs
2
Description
Intervention group 2: Under the liberal fluid treatment before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Mahzad Alimian
Street address
Rasool Akram Hospital, Maziar Mansouri Ave, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6651 5001
Fax
Email
alimian.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahzad Alimian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram Hospital, Maziar Mansouri Ave, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
mahzadalimian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahzad Alimian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram Hospital, Maziar Mansouri Ave, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
mahzadalimian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Moazami
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram Hospital, Maziar Mansouri Ave, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
mahzadalimian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The whole potential data is unpublished after being unidentifiable.
When the data will become available and for how long
Start the access period 6 months after printing the results.
To whom data/document is available
Researchers working in academic and industrial institutions.
Under which criteria data/document could be used
It can be used to carry out research work.
From where data/document is obtainable
Dr. Mahzad Alimian, Faculty of Medicine, Iran University of Medical Sciences.
What processes are involved for a request to access data/document