Comparison of the effect of intravenous catheter washing with Heparin, Normal saline, and Taurolock solution on phlebitis severity
Design
Clinical trial with a control group, with parallel groups, one-way blind, randomized, on 80 patients (4 groups of 20 people). Excel software rand function was used for randomization.
Settings and conduct
Shafa Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Absence of vascular disorders; The patient should be alert and have proper communication; Healthy feeling of pain; No wounds or trauma to an organ with an intravenous catheter.
Exclusion criteria: Patients with heparin allergy; History of coagulation disorders and warfarin tablets; Contraindications to heparin and tarolac.
Intervention groups
Intervention group 1: In the first group (washing the catheter with heparin solution); Diluted heparin solution at a concentration of 100 units / ml is injected every 8 hours in a volume of 12 units with an insulin syringe into intravenous catheters (angiocatheter) and lasts up to 72 hours.
Intervention group 2: In the second group (rinsing the catheter with normal saline solution); Normal saline 0.9% sterile infusion for infusion is injected every 8 hours in a volume of 12 units with an insulin syringe into intravenous catheters (angiocatheter) and lasts up to 72 hours.
Intervention group 3: In the third group (rinsing the catheter with tarolak solution); Trolidine citrate solution (brand name Tarolak) with a volume of 12 units (insulin syringe) is injected every 8 hours into intravenous lines (angiocatheter) and lasts up to 72 hours.
Control group: Only routine procedures and care are performed.
Main outcome variables
Phlebitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N56
Registration date:2020-10-20, 1399/07/29
Registration timing:registered_while_recruiting
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous catheter washing with Heparin, Normal saline, and Taurolock solution on phlebitis severity
Public title
Comparison of the effect of intravenous catheter washing with Heparin, Normal saline, and Taurolock solution on phlebitis severity
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of vascular disorders
The patient should be alert and have proper communication
Healthy feeling of pain
No wounds or trauma to an organ with an intravenous catheter
Exclusion criteria:
Patients with heparin allergy
History of coagulation disorders and warfarin tablets
Contraindications to heparin and tarolac
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 4).
Using Excel software to generate random number tables
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of the type of grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.SEMUMS.REC.1399.164
Health conditions studied
1
Description of health condition studied
Thrombophlebitis
ICD-10 code
I80
ICD-10 code description
Phlebitis and thrombophlebitis
Primary outcomes
1
Description
Phlebitis
Timepoint
24, 48, and 72 hours after intervention
Method of measurement
Phlebitis Jackson Observation Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In the first group (washing the catheter with heparin solution); Diluted heparin solution at a concentration of 100 units / ml is injected every 8 hours in a volume of 12 units with an insulin syringe into intravenous catheters (angiocatheter) and lasts up to 72 hours.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the second group (rinsing the catheter with normal saline solution); Normal saline 0.9% sterile infusion for infusion is injected every 8 hours in a volume of 12 units with an insulin syringe into intravenous catheters (angiocatheter) and lasts up to 72 hours.
Category
Treatment - Drugs
3
Description
Intervention group 3: In the third group (rinsing the catheter with tarolak solution); Trolidine citrate solution (brand name Tarolak) with a volume of 12 units (insulin syringe) is injected every 8 hours into intravenous lines (angiocatheter) and lasts up to 72 hours.
Category
Treatment - Drugs
4
Description
Control group: Only routine procedures and care are performed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Mohammadreza Asgari
Street address
Twenty meters Vahdat Street, Semnan
City
Semnan
Province
Semnan
Postal code
3519899543
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Shirashiani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kowsar Hospital, Amin Street.
City
Semnan
Province
Semnan
Postal code
3514614172
Phone
+98 23 3365 4162
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available