The effect of regulating the flow rate of cardiopulmonary bypass pump based on lean body mass index on mixed venous blood oxygen and arterial blood lactat level among patients with abnormal range of body mass index
Main objective: effect of calculated blood flow rate based on Lean Body Mass Index during Cardiopulmonary Bypass on mixed venous oxygen saturation and arterial blood lactate level among patients with abnormal Body Mass Index.
This study was designed as a randomized clinical trial with a control group which will be done in patients with body mass index more than 25.
Setting: in this study, 152 patient undergoing Cardiac Surgery by Cardiopulmonary Bypass are classified randomly in two groups of intervention and control. Patients specifically are chosen between body mass index range of 25-35 which have been defined as overweight (body mass index 25-29) and obese (body mass index 30-35).
Inclusion criteria are, 18-70-year-old patients who do not have history for respiratory, renal and hepatic disease, more than 70% one-side or 50% two-side carotid stenosis and cardiac surgery by Cardiopulmonary Bypass.
pump Flow Rate for each patient is calculated based on Lean Body Mass In intervention group and Body Surface Area in control group.
Research variables are blood lactate level and mixed venous oxygen saturation which are supposed to be measured in specified periods
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012932276N1
Registration date:2017-06-27, 1396/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Parvin Vahid
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
vahid.p@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Iran University of Medical Science
Expected recruitment start date
2017-05-19, 1396/02/29
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of regulating the flow rate of cardiopulmonary bypass pump based on lean body mass index on mixed venous blood oxygen and arterial blood lactat level among patients with abnormal range of body mass index
Public title
The effect of regulating the flow rate of cardiopulmonary bypass pump based on lean body mass index on mixed venous blood oxygen and arterial blood lactat level among patients with abnormal range of body mass index
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1، Older than 18 years old 2، body mass index of between 25-35 3،open heart surgery with the use of cardiopulmonary bypass 4،not having disorder in kidney, lung, liver and cerebral and treatment-resistant hypertension 5, left ventricular ejection fraction more than 30% 6، patients with bilateral carotid artery stenosis greater than 50% or unilateral carotid stenosis greater than 70% 7,patients elective open heart surgery
exclusion criteria from the study:
1 , any event that affect the normal process of open heart surgery include cardiopulmonary bypass requirement though surgery, persistent decline of blood pressure through cardiopulmonary bypass that not respond to Inotropic drug 2, death 3, aortic clamping time over 100 minutes 4, temperature reduction below 28 degree during operation for any reason the surgeon decide to catch a lower temperature than 28 degree
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Allocation of samples in the form of blocks Random can be done using a computer
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran Univercity of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat highway, Tehran, Iran
City
Tehran
Postal code
1449614535
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
IR.IUMS.REC 1395.9311584005
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease, so described
Primary outcomes
1
Description
on mixed venous oxygen saturation
Timepoint
after anesthesia,during cardiiopulmonary bypass,after cardiopulmonary bypass
Method of measurement
content of each gas in arterial blood Under the pressure of eac gas
2
Description
arterial blood lactate
Timepoint
after anesthesia,during cardiiopulmonary bypass,after cardiopulmonary bypass
Method of measurement
arterial blood sample
Secondary outcomes
1
Description
o2 consumption
Timepoint
during cardiopulmonary bypass
Method of measurement
content of each gas in venous blood Under the pressure of eac gas and pump flow rate
Intervention groups
1
Description
In this study, in the intervention group, patients with BMI over 25, obtained number from lean body mass will be multiplied by 2.4 and according to it pump flow will be arranged in cardiopulmonary bypass machine. After anesthesia, first blood sample will be taken using 2 ml heparinized syringe from radial artery and the venous blood sample will be taken from the central venous. Second blood sample will be obtained after cross- clamped of the aorta and cardioplegia induction. During rewarming and after declamping in temperature between 35-37 degree, third sample will be taken from oxygenator arterial line sample and venous reservoir entrance, respectively. In case of long surgery procedures, sampling will be repeated every half an hour. Finally, based on gained samples, measuring arterial lactate level and mixed venous oxygen saturation will be done.
Category
Prevention
2
Description
In this study, in the control group, patients with BMI over 25, obtained number from bodr sueface area will be multiplied by 2.4 and according to it pump flow will be arranged in cardiopulmonary bypass machine. After anesthesia, first blood sample will be taken using 2 ml heparinized syringe from radial artery and the venous blood sample will be taken from the central venous. Second blood sample will be obtained after cross- clamped of the aorta and cardioplegia induction. During rewarming and after declamping in temperature between 35-37 degree, third sample will be taken from oxygenator arterial line sample and venous reservoir entrance, respectively. In case of long surgery procedures, sampling will be repeated every half an hour. Finally, based on gained samples, measuring arterial lactate level and mixed venous oxygen saturation will be done
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
rajaei cardiovascular, medical& reaserch center
Full name of responsible person
Parvin Vahid
Street address
Rajaei Cardiovascular, Medical & reaserch center, ValiAsr and Niayesh expy intersection
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
iran univercity of medical science
Full name of responsible person
Technology and Research Deputy of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
iran univercity of medical science
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 Science
Full name of responsible person
Parvin Vahid
Position
masters student of cardiovascular perfusion technology
Other areas of specialty/work
Street address
School of Nursing, Iran University of Medical Sciences, Rashid Yaasemi street, Valiasr street
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Fax
+98 21 8888 2886
Email
vahid .p@tak.iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of nursing & midwifery of Iran University of Medical Science
Full name of responsible person
dr Tahereh Najafi Ghezeljeh
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
School of Nursing, Iran University of Medical Sciences, Rasheed Yaasemi street, Valiasr street
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
najafi.t@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of medical Science
Full name of responsible person
Parvin Vahid
Position
masters student of cardiovascular perfusion tecnology
Other areas of specialty/work
Street address
School of Nursing, Iran University of medical Sciences, Rashid Yaasemi street, Valiasr street
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
vahid.p@tak.iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)