Determining the effect of intermediate dose of heparin solution in the prevention of central vein catheter occlusion on ICU admitted patients admitted to intensive care unit
Design
A controlled clinical trial with parallel groups, double-blind, simple randomized, phase 3 will be performed on 153 patients. Random number table will be used in Excel software for randomization.
Settings and conduct
Patients who will be hospitalized in the intensive care unit of Imam Reza Hospital of Mashhad and will be have a central venous catheter implanted (less than 12 hours) will be entered in this study. In each patient, the lines will be divided into two categories: active or inactive. Blinding will be done using opaque, sealed and sealed envelopes.
Participants/Inclusion and exclusion criteria
Patients admitted to the intensive care unit with triceps central venous catheters, which are less than 12 hours after implantation and all its lines are functional, are included in the study.
Exclusion criteria: patients who dialysis and freezing catheters and pulmonary artery catheters; implant ports; age less than 18 years old; pregnant women; heparin sensitivity; receive complete intravenous nutrition during the study period; active lines that need more than 3 times heparinazation will be excluded.
Intervention groups
Active and Inactive lines in the intervention group are washed every 8 hours with 10 ml of saline solution and then locked with 1.5 ml of heparin solution (at a concentration of 100 units per ml).
Main outcome variables
Central vein catheter occlusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190905044704N1
Registration date:2021-08-19, 1400/05/28
Registration timing:prospective
Last update:2021-08-19, 1400/05/28
Update count:0
Registration date
2021-08-19, 1400/05/28
Registrant information
Name
Asieh Yahyaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 3763
Email address
yahyaeia961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intermediate dose of heparin solution in the prevention of central vein catheter occlusion on ICU admitted patients
Public title
Effect of heparin in the prevention of central vein catheter
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All ICU admitted patients who had 3 functional lumen catheter that insert less than 12 hours
Exclusion criteria:
Dialysis and phresis and pulmonary artery catheters and insertable ports
Age less than 18 y/o
Pregnancy
Heparin sensivity and HIT
Coagolation system disorder and thrombocytopenia
Therapeutic dose of anticoagolant
Packed cell or any blood products transfusion
TPN
If the active lines needed more than 3 time hepparizination were excluded
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization in this way that Heparin and normal saline solution divided in number "one" and number "two" solution that nurse and patient do not know that and use this solution for patients with randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Heparin and normal salin solution divided in number one and number two solution that nurse and patient do not know that.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Science
Street address
Office off Research and Technology, Ghoreishi Building, Near Hoveize Cinema, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-10-25, 1398/08/03
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.431
Health conditions studied
1
Description of health condition studied
Central vein catheters occlution
ICD-10 code
T85
ICD-10 code description
Complications of other internal prosthetic devices, implants and grafts
Primary outcomes
1
Description
Central vein catheter occlution
Timepoint
Central vein catheters was checked every 8 hours untill 14 days
Method of measurement
Aspiration and infusion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The active and inactive lines in the intervention group will be washed every 8 hours with 10 ml of saline solution and then locked with 1.5 ml of heparin solution at a concentration of 100 units per ml untill 14 days.
Category
Treatment - Drugs
2
Description
Control group: In the control group, only saline washing will be performed untill 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Asieh Yahyaie
Street address
ICU C, second floor, Edalatian Department, Emam Reza Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 3763
Email
yahyaeia961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Bagheri Moghadam
Street address
ICU C, Second floor, Edalatian Department, Emam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 3763
Email
yahyaeia961@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Asieh Yahyaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
ICU C, second floor, Edalatian Department, Emam Reza Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 3763
Email
yahyaeia961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Asieh Yahyaie
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
ICU C, second floor, Edalatian Department, Emam Reza Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 3763
Email
yahyaeia961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Asieh Yahyaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
ICU C, second floor, Edalatian Department, Emam Reza Hospital,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 3763
Email
yahyaeia961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is shared after unidentifiable people
When the data will become available and for how long
6 months after publishing
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Use data to compare with other similar interventions
From where data/document is obtainable
bagheria@mums.ac.ir
What processes are involved for a request to access data/document