In this study with the goal of comparison of serum viscosity between patients whom infused human serum albumin5% with the patients whom infused normal saline, patients with ASA class I and II in the range of 20 to 50 years old candidate for low to moderate risk minor surgery .Without a history of hypertension, diabetes mellitus, ischemic heart disease, coagulopathy, receiving anti coagulant and antiplatlate factors and BMI higher than 30 and surgery duration longer than 2 hours and large fluid shift during surgery were selected randomly in two group of 28 cases .10ml.of venous blood obtained in the heparinised syringe(containing 1000 unit heparin) from all patient before fluid infusion and also one hour after the end of fluid infusion ( on liter of normal saline or albumin 5%) and the blood samples kept immobile for several hours and then after the separation of the serum phase from the blood cells. the serum transferred to a 20 ml. syringe and this syringe connected to an infusion pump with a rate of 1 ml per minute while a 3- way stop-cock placed at the exit of the syringe. The serum had two ways to pass through them: 1) a 23 gauge needle. 2) Through an extension tube which was filled with distilled water. The height of the column of the water in the extension tube in millimeter was recorded and the viscosity value calculated with loading this formula: η = (π p r4)/(8' Q l)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022312573N1
Registration date:2013-08-18, 1392/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Mozhde Jalali
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8504
Email address
jalali_m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research -Tehran University of Medical Science
Expected recruitment start date
2012-12-20, 1391/09/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of serum viscosity between patients whom infused human serum albumin5% with the patients whom infused normal saline
Public title
effect of saline and albumin %5 on serum viscosity
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: All patients with ASA class I and II in the range of 20 to 50 years old candidated for low to momerate risk minor surgery.
Exclusion criteria: patients with a history of hypertension; diabetes mellitus; ischemic heart disease; coagulopathy; receiving anti coagulant and antiplatlate factor; patients with BMI highier than 30; surgery duration longer than 2 hours and large fluid shift( more than 60ml/kg crystalloid infusion needed) during surgery
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Central Department of Tehran University, 6th Floor, Qods Ave, keshavarz boulevard, Tel.: 02188987381-2
City
Tehran
Postal code
Approval date
2013-01-23, 1391/11/04
Ethics committee reference number
2738/130/د/91
Health conditions studied
1
Description of health condition studied
plasma viscosity
ICD-10 code
R70.1
ICD-10 code description
Abnormal plasma viscosity
Primary outcomes
1
Description
blood serum viscosity
Timepoint
before infusion of any fluid ,one hour after infusion of normal saline or albumin 5%
Method of measurement
5cc of patient's serum was transfused with a rate of 1 ml per minute while a 3- way stop-cock placed at the exit of the syringe. The serum had two ways to pass through them: 1) a 23 gauge needle. 2) Through an extension tube which was filled with distilled water. The height of the column of the water in the extension tube in millimeter was recorded and the viscosity value calculated with loading this formula: η = (π p r4)/(8' Q l)
Secondary outcomes
1
Description
1)determine the serum viscosity by age.2) determine the serum viscosity by the type of anesthesia 3)detrimine the serum viscosity by the type of surgery
Timepoint
befor infusion of any fluid
Method of measurement
5cc of patient's serum was transfused with a rate of 1 ml per minute while a 3- way stop-cock placed at the exit of the syringe. The serum had two ways to pass through them: 1) a 23 gauge needle. 2) Through an extension tube which was filled with distilled water. The height of the column of the water in the extension tube in millimeter was recorded and the viscosity value calculated with loading this formula: η = (π p r4)/(8' Q l)
Intervention groups
1
Description
IV infusion of normal saline over one hour in control group
Category
Diagnosis
2
Description
IV infusion of serum albumin 5% over one hour in intervention group
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Operation room of Sina hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Public Health, Tehran University of Medical
Full name of responsible person
Dr. Akbar Fotuhi
Street address
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, PO Box: 14155-6446
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Public Health, Tehran University of Medical
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
Tehran University of Medical Science
Full name of responsible person
Dr. Mozhde Jalali
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Tehran, Emam Khomeini Ave. Sina Hospital
City
Ttehran
Postal code
Phone
+98 21 6634 8504
Fax
Email
jalali_m@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr.Farhad Etezadi
Position
Assistant
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 6634 8504
Fax
Email
etezadi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Atabak Najafi
Position
Associated Professor
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)