Occlusion of central venous catheters is one of the limiting factors in using them. Heparinised saline solution is the standard solution used for keeping the catheters open. The goal of this study was determining the effect of heparin saline solution and normal saline in maintenance of patency of central venous catheters.
Methods: this double-blind study was performed on 84 intensive care unit patients who had central venous catheters. The patients were randomly divided into two groups of heparin saline receivers and normal saline receivers. In the heparin group after each drug injection into the lumen 3cc of heparin saline solution was injected in the catheter as well. The other group only received 10cc of normal saline instead. The catheters were examined for blood return and flushing every 8 hours for 21 days. Analysis of the data was performed using SPSS software version 20 and descriptive and analytic statistics were studied.
General information
Acronym
Heparin and 0.9% sodium chloride solutions for central venous catheters
IRCT registration information
IRCT registration number:IRCT2014050613156N5
Registration date:2014-05-17, 1393/02/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-17, 1393/02/27
Registrant information
Name
Mohammad Ali Heydari Gorji
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7342
Email address
mheydarigorji@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for reaserch Mazandaran university of medical science
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of heparin and 0.9% sodium chloride solutions in maintenance of patency of central venous catheters in intensive care unite
Public title
Comparison of the effects of heparin and 0.9% sodium chloride solutions in maintenance of patency of central venous catheters
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: age 18-60 years old; time passed from insertion of the catheter would be less than 12 hours; usage of triple lumen silicone catheters; patient’s blood platelet of 150000-450000; PT of 11-12.5 seconds; PTT in the range of 35-45 seconds and having received 1 liter of serum KVO during 24 hours
Exclusion criteria: risk of bleeding; receiving blood products during study and an increase in body temperature higher than 37.7 C.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Mazandaran university of medical science
Street address
Iran, Sari, Moallem SQ, Moallem street
City
Sari
Postal code
4763654811
Approval date
2014-03-07, 1392/12/16
Ethics committee reference number
67-92
Health conditions studied
1
Description of health condition studied
CVA
ICD-10 code
G90.3
ICD-10 code description
G90.3
Primary outcomes
1
Description
Maintenance of patency of central venous catheters
Timepoint
Each 8 hours for 21 days
Method of measurement
Chek list
Secondary outcomes
1
Description
Hemoraghia
Timepoint
Each 8 hour for 21 days
Method of measurement
Chek list
Intervention groups
1
Description
Heparin group: In the heparin group patient's solution will be prepared by a 1000 unit heparin ampoule will being added to half a liter normal saline and so each milliliter of the prepared solution will be contained 10 units of heparin. After injection of the drugs to patients 3 mL of this solution will be injected as well. Catheters will be examined by the researcher for blood return and flushing every 48 hours using patients medical data sheet . During the examination of the condition of the catheters all the patients were laying on their backs. If after this maneuver there was not a possibility of flushing or taking blood sample from the catheter the catheter was considered non-functional and was removed.
Category
Treatment - Drugs
2
Description
Normal salin group: In normal saline group patients 10mL 0.9% sodium chloride was injected in each lumen of the catheter. Method will be done acording
heparin group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Ayatollah Roohani Hospital
Full name of responsible person
Fatemeh Rezaei
Street address
Nasibeh Nursing and Midwifery, Veal Street, Sari, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for reaserch Mazandaran University of Medical science
Full name of responsible person
Ahmad Ali Enayati
Street address
Moallem street,Moallem sq, Sari, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for reaserch Mazandaran University of Medical science
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Heydarigorji
Position
P.h.D in nursing
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery, Veal Street, Sari, Iran
City
Sari
Postal code
4763654811
Phone
+98 15 1226 7342
Fax
Email
heydarigorji@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Hedayat Jafari
Position
P.h.D student of nursing
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery, Veal Street, Sari, Iran
City
Sari
Postal code
Phone
+98 15 1226 7342
Fax
Email
jafarih2010@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Fatemeh Rezaei
Position
MSC in critical care nursing
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery, Veal Street, Sari, Iran
City
Sari
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)