Clinical trial comparing blood flow pulsating heart pumps to assist patients with non-pulsating flow of blood pumped during the patient's kidney function in the proximal graft surgery, coronary artery bypass grafting
Objectives: Given the limited studies that have been conducted regarding the pulsating heart. We decided to investigate the impact pulsating blood flow pump to help heart patients on renal function in the proximal graft during surgery, coronary artery bypass Yepes in Baqiyatallah Hospital.
Design: This is a triple-blind, randomized clinical trial. Setting and conduct: This study will perform at the Baqiyatallah University of Medical Sciences.
Patients in both groups will divide randomly using a table of random numbers. Count of Bacteria is another outcome in this study and assess using the laboratory. This clinical trial is a phase 2 study. Major Inclusion and Exclusion criteria: patients referred for coronary artery bypass grafting after obtaining informed consent. Emergency patients, obese BMI greater than 40, has a history of heart surgery, a history of liver disease and impaired liver function tests and patients with insulin-dependent diabetes, kidney disease or high creatinine are excluded.
Intervention: 36 patients using pulsating blood flow pump to help heart rate and blood flow in 36 patients with non-pulsating pump will be evaluated.
During the intervention the proximal graft in coronary artery bypass grafting done.
Main outcome measures (variables): Variables kidney function, including creatinine and blood urea nitrogen (B.U.N).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102230421N1
Registration date:2017-05-15, 1396/02/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-15, 1396/02/25
Registrant information
Name
Marzieh Lak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 9013
Email address
marziehlak@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-04-24, 1394/02/04
Expected recruitment end date
2016-04-29, 1395/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing blood flow pulsating heart pumps to assist patients with non-pulsating flow of blood pumped during the patient's kidney function in the proximal graft surgery, coronary artery bypass grafting
Public title
Effect of pulsatile blood flow pumps to help heart patients on renal function during surgery graft proximal coronary artery bypass grafting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients referred for coronary artery bypass grafting after obtaining informed consent Exclusion criteria were included: emergency patients, obese BMI greater than 40, has a history of heart surgery, a history of liver disease and impaired liver function tests and patients with insulin-dependent diabetes, kidney disease or high creatinine are excluded.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Baqiyatallah University of Medical Sciences
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
1435917541
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
ir.bmsu.rec.1394.171
Health conditions studied
1
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Inotrope
Timepoint
After intervention in ICU, one and two days after intervention
Method of measurement
Clinical
2
Description
Creatinine
Timepoint
After intervention in ICU, one and two days after intervention
Method of measurement
Laboratory
Secondary outcomes
1
Description
Blood urea nitrogen (BUN)
Timepoint
After intervention in ICU, one and two days after intervention
Method of measurement
Laboratory
Intervention groups
1
Description
Intervention group: With about a third of tidal volume ventilation began air volume. When the heart begins to beat with HR greater than 60 and the regular rhythm of heart through a partial obstruction in the tube by tube clump Back venous pumping action of the heart have to fill out so that the Rtrlayn monitor pulse rate were observed.
Category
Treatment - Surgery
2
Description
Control group: routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery Department of Baqiyatallah hospital
Full name of responsible person
Marzieh Lak
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Hamid Reza Rasouli
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Baqiyatallah University of Medical Sciences
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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Marzieh Lak
Position
Faculty member/Anesthesiologist
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Fax
Email
marziehlak@bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Marzieh Lak
Position
Faculty member/Anesthesiologist
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Fax
Email
marziehlak@bmsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Marzieh Lak
Position
Faculty member/Anesthesiologist
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Fax
Email
marziehlak@bmsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)