Evaluation the effect of pulsatile perfusion during cardiopulmonary bypass on cerebral tissue oxygenation and arterial blood lactate leveles in patients undergoing valvular heart Surgery
The main objective of this study is Evaluation the effect of pulsatile perfusion during cardiopulmonary bypass on cerebral tissue oxygenation and arterial blood lactate leveles in patients undergoing valvular heart surgery, design the study is a randomized trial with a control group, 70 patiens undergoing valvular heart surgery who have inclusion criteria randomly divided into two intervention and control groups.in the intervention group patients undergoing valvular heart surgery during aortic cross clamping time received pulsatile perfusion and in control group received routine perfusion(non pulsatile).
The primary outcome variables is arterial lactate levels and cerebral oxygenetion
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101130266N1
Registration date:2017-08-26, 1396/06/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-26, 1396/06/04
Registrant information
Name
Samira Moosaei Far
Name of organization / entity
IranUniversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4686 1884
Email address
mosaeifar.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor Of Research, Iran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of pulsatile perfusion during cardiopulmonary bypass on cerebral tissue oxygenation and arterial blood lactate leveles in patients undergoing valvular heart Surgery
Public title
Evaluation the effect of pulsatile perfusion during cardiopulmonary bypass on cerebral tissue oxygenation and arterial blood lactate leveles in patients undergoing valvular heart Surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: patients with valvular heart disease that needs surgical replacement or repair of heart valves, body surface area less than 2, Age 18 to 65, Estimated cardiopulmonary bypass time greater than 60 minute, Left ventricle ejection fraction(LVEF) 40% and greater than 40%
Exclusion criteria: patients with carotid stenosis, atherosclerosis of ascending aorta and aortic arch, history of cerebrovascular accident, diabetic patient, hepatic disorders, alcoholism, patients needs emergency or complicated and redo surgeries, congenital heart disease, pregnancy, patients disagreement(without consent), preoperation arterial lactate levels greater than 2 miliigram per deciliter, arteial blood gases not in normal rang during cardiopulmonary bypass, patients who needs intraaortic baloon pump(IABP), extracorporeal membrane oxygenation(ECMO) or patients with open sternum, cardiac arrest
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is randomized controlled clinical trial with blocked randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway, Tehran
after anasthasia and mechanical ventilation, after aortic cross clamping, after aortic cross clamp removal, termination of cardiopulmonary bypass, 2 and 4 hours post operation room
Method of measurement
arterial blood sample ( our lab reference unit is milligram per decilitre)
2
Description
cerebral oxygenetion
Timepoint
During the whole time of surgery and cardiopulmonary bypass
Method of measurement
To evaluate cerebral oxygenetion we use INVOS cerebral /somatic oxymeter, the values are measured continuously as a percentage of oxygen saturation
Secondary outcomes
1
Description
Liver enzymes(AST& ALT)
Timepoint
Pre & Post operation
Method of measurement
blood sample(our lab reference unit is Unit per liter)
2
Description
Renal function tests( BUN & Cr)
Timepoint
Pre & Post operation
Method of measurement
blood sample(our lab reference unit is milligram per deciliter)
3
Description
Lactate dehydrogenase(LDH)
Timepoint
Pre & Post operation
Method of measurement
blood sample( our lab reference unit is Unit per liter)
4
Description
Platelet count
Timepoint
Pre & Post operation
Method of measurement
blood sample(our lab reference unit is platelete count per microliters)
5
Description
Urine out put
Timepoint
Pre CPB, Pre aortic cross clamp, after removal of aortic cross clamp, termination of CPB
Method of measurement
Through direct vision urine volume(in millilite)r is measured by collecting in urine bag
Intervention groups
1
Description
During open heart surgery when patient is on cardiopulmonary bypass after aortic cross clamping and cardioplegic arrest patients undergoing pulsatile perfusion.
pulsatile features on heart lung machine set as following: frequency: 70 beat per minute, pulse width: 50%, base flow: 30%( 70%pulsatile and 30% nonpulsatile)
Category
Other
2
Description
In control group during cardiopulmonary bypass after aortic cross clamping patients undergoing routine(non pulsatile) perfusion.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajayi Cardiac Hospital
Full name of responsible person
Street address
Shahid Rajayi Cardiac Hospital, Niayesh Highway, Valiasr Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Iran University of Medical Sciences
Full name of responsible person
Seyyed Ali Javad Moosavi
Street address
Iran University of Medical Sciences, Shahid Hemmat highway, 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 Of Research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Samira Moosaei Far
Position
Post Graduate Student in Cardiovascular Perfusion Technology
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Shahid Rashid Yasemi Street, Valiasr Street, Tehran