Effect of variability of central venous pressure values to prevent atrial fibrillation after coronary by pass grafting
Design
A Non-randomized clinical trial with parallel groups. 150 patients have divided into intervention 3 groups A, B and C.
Settings and conduct
The study population consisted of patients who referred to Ayatollah Rouhani
Hospital in Babol. Group 1: Normal pressure group (8 to 12 mmHg)
Group 2: Low pressure group (less than 8), Group 3: High pressure group (greater than 12), During hospitalization with central venous pressure treatment, we normalized central venous pressure in all 3 groups. In the low pressure group of fluid delivery and, if necessary, vasopressor, and the high-pressure group performed fluid restriction and Furosemide injection.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients undergoing isolated coronary artery bypass graft surgery
Exclusion Criteria:History of atrial fibrillation Renal failure with plasma creatinine greater than 2 mg/dl, Malignant or inflammatory diseases, Mixed cardiac operations including valve replacement, Active hepatic-biliary diseases
Intervention groups
Group 1: Normal pressure group (8 to 12 mmHg)
Group 2: Low pressure group (less than 8)
Group 3: High pressure group (greater than 12)
During hospitalization with central venous pressure treatment, we normalized central venous pressure in all 3 groups. In the low pressure group of fluid delivery and, if necessary, vasopressor, and the high-pressure group performed fluid restriction and Furosemide injection.
Main outcome variables
Atrial fibrillation after Coronary Artery Bypass Graft surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190928044907N1
Registration date:2019-09-29, 1398/07/07
Registration timing:retrospective
Last update:2019-09-29, 1398/07/07
Update count:0
Registration date
2019-09-29, 1398/07/07
Registrant information
Name
seyed hossein hamidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3222 3301
Email address
a.hamidi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
2019-03-11, 1397/12/20
Actual recruitment end date
2019-09-21, 1398/06/30
Trial completion date
2019-09-21, 1398/06/30
Scientific title
Effect of variability of central venous pressure values to prevent atrial fibrillation after coronary by pass grafting
Public title
Effect of variability of central venous pressure values to prevent atrial fibrillation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing isolated coronary artery bypass graft surgery
Exclusion criteria:
History of atrial fibrillation
Renal failure with plasma creatinine greater than 2 mg/dl
Malignant or inflammatory diseases
Mixed cardiac operations including valve replacement
Active hepatic-biliary diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.009
Health conditions studied
1
Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Atrial fibrillation after Coronary Artery Bypass Graft surgery
Timepoint
During 5 days after operation
Method of measurement
ECG monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Low pressure group (less than 8),Treatment of central venous pressure In the low pressure group by giving fluid and vasopressor if necessary.
Category
Prevention
2
Description
Intervention group2 : High pressure group (greater than 12), Treatment of central venous pressure In the high-pressure group by limiting fluids and giving 40 mg of Furosemide.
Category
Prevention
3
Description
Control group: Normal pressure group (8 to 12 mmHg)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Seyed Hossein Hamidi
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
s.hosseinhamidi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
seyed hossein Hamidi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3223 8301
Email
s.hosseinhamidi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
seyed hossein Hamidi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
s.hosseinhamidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyed Hossein Hamidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
s.hosseinhamidi@yahoo.com
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
There is still no plan for its publish.
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