Investigation of the Local Effect of bovine ghee on complication after Angiography in Patients Under Coronary Angiography Admitted to Ali-ibn Abitaleb Hospital in Rafsanjan City in 2018-2019
Determination of the Local Effect of bovine ghee on complication after Angiography in Patients Under Coronary Angiography
Design
The intervention was divided into three groups with blind post-operative care and the results were randomly blocked
Settings and conduct
Patients for the coronary angiography (N=135) will be randomly divided to the control group and the two intervention groups.
One hour before performing per-cutaneous angiography through the right femoral artery, intervention will be performed in groups, and every 12 hours will be repeated. Angiography location is checked at the first hour every 30 minutes and then at 2, 4, 6 and 10 hours after the angiography and the next day morning it will be controlled.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Performing angiography via femoral artery
Lack of underlying illnesses
Using Sheath 6
Not having known psychiatric disorders, fluency in Farsi and ability to communicate
Their systolic blood pressure is less than 130 when withdrawal of arterial sheath
Lack of ecchymosis, hematoma and hemorrhage in the angiography site
Not taking steroids, heparin and enoxaparin
Age more than 18 years old
Exit criteria:
Drug side effects
History of localized allergy to animal oil
The incidence of nonvascular complications of angiography
Incidence of acute cardiac complications
Any factor that causes the patient to get out of the reach of 48 hours
Intervention groups
In the first intervention group (Sheep oil), a gas impregnated with sheep's oil, and in the second intervention group (Cow oil) a gas impregnated with cattle oil. localized 10 x 10 cm in the groin is used in the femoral artery. In the control group, Vaseline cream is used as a placebo in the same amount.
Main outcome variables
Study of the symptoms of hemorrhage and hematoma and ecchymosis by checklist in the studied groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180729040630N2
Registration date:2019-03-11, 1397/12/20
Registration timing:registered_while_recruiting
Last update:2019-03-11, 1397/12/20
Update count:0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Mohammad Ali Zakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3429 2316
Email address
mazakeri@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Local Effect of bovine ghee on complication after Angiography in Patients Under Coronary Angiography Admitted to Ali-ibn Abitaleb Hospital in Rafsanjan City in 2018-2019
Public title
Local Effect of sheep ghee on complication after Angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing coronary angioplasty Performing angiography via femoral artery Lack of heart failure Lack of COPD Lack of kidney failure Lack of severe valve disease Lack of liver failure Lack of Blood disorders Using Sheath 6 to access the artery pathway Not having known psychiatric disorders Fluency in Farsi and ability to communicate Systolic blood pressure is less than 130 Lack of ecchymosis in the angiography site Lack of hematoma in the angiography site Lack of hemorrhage in the angiography site Not taking steroids, heparin and enoxaparin Age more than 18 years old
Exclusion criteria:
Drug side effects History of localized allergy to animal oil The incidence of non-vascular complications of Angiography in the patient Types of cardiac dysrhythmia Contrast agents Cardiac tamponed Cerebrovascular accident (CVA) Pulmonary edema Cardio-respiratory arrest Decreased consciousness Angioplasty Emergency Surgery Lack of cooperation Personal satisfaction and discharge
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Random block
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind study. Participants and researchers are unaware of the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Bulvar, Rafsanjan.
City
Rafsangan
Province
Kerman
Postal code
7717933777
Approval date
2018-12-23, 1397/10/02
Ethics committee reference number
IR.RUMS.REC.1397.167
Health conditions studied
1
Description of health condition studied
Complications after Angiography
ICD-10 code
D69.9
ICD-10 code description
Bleeding
Primary outcomes
1
Description
complication after Angiography
Timepoint
Before and after intervention
Method of measurement
Christenson's guideline, Visual Satisfaction Scale of Patients, Visual Scale of Pain And Fatigue Assay Scale for Routine Patients
Secondary outcomes
1
Description
Satisfaction of Patients
Timepoint
Before and after intervention
Method of measurement
Visual Satisfaction Scale of Patients
2
Description
pain
Timepoint
Before and after intervention
Method of measurement
Visual analogue pain scale
Intervention groups
1
Description
Intervention group: Cow oil
Category
Treatment - Other
2
Description
Intervention group: Sheep oil
Category
Treatment - Other
3
Description
Control group: Vaseline cream
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan University of Medical Sciences
Full name of responsible person
Hassan Pakdaman
Street address
Imam Ali Bolvar, Rafsanjan
City
Rafsangan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0011
Fax
Email
h.pakdaman@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsi zadeh
Street address
Imam Ali Bolvar, Rafsanjan
City
Rafsangan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Ali Zakeri
Position
Master of Science (MSc) in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rafsanjan, Imam Ali Bolvar
City
Rafsangan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0011
Email
mazakeri@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Ali Zakeri
Position
Master of Science (MSc) in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Ali Bolvar, Rafsanjan
City
Rafsangan
Province
Kerman
Postal code
7717933777
Phone
+98 34342316
Email
ma.zakeri115@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Ali Zakeri
Position
Master of Science (MSc) in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Ali Bolvar, Rafsangan
City
Rafsangan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0011
Email
mazakeri@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
Undecided - It is not yet known if there will be 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