Comparison effect of plasmalite A and lactate ringer in prime solution on acid and base status and electrolytes)Na.K.Ca)and lactate level and blood sugure in people with Diabet undergoing cardiac surgery with cardiopulmonary bypass
Determining the effect of plasmalyte A and Ringer's lactate in Prime solution on acid and base status and electrolytes (sodium, potassium, calcium) and lactate and blood sugar levels in people with diabetes undergoing heart surgery with cardiopulmonary bypass at Shahid Rajaei Cardiovascular Center
Design
RCT clinical trial (randomized controlled clinical trial) in two groups in parallel time and place and phase 3 on 60 patients and double-blind
Settings and conduct
A randomized and prospective controlled study is conducted on a total of 60 adult patients undergoing CPB for cardiac surgeries. Patients are divided into 2 groups: group I (Ringer Lactate) and group II (Plasmalyte-A) arterial blood sample before starting CPB, after starting CPB, then every hour until the end of the operation and then upon entering the ICU and After that, at 6, 12, 18, and 24 hours, for the purpose of analysis in the table of electrolytes and acid-base balance, lactate and blood sugar levels are considered.The participant and the clinical observer are unaware of the outcome
Participants/Inclusion and exclusion criteria
1- Age above 17 years
2- Elective surgeries
3- The first time of heart surgery (CABG) and valvular surgery
4- LVEF>30%
5- Being diabetic
Intervention groups
The intervention group is the people receiving plasmolyte and the control group is the people receiving Ringer's serum
Main outcome variables
Acid and base conditions
Electrolytes (sodium, potassium, calcium) in the blood
Blood lactate level
blood sugar
In people with diabetes
General information
Reason for update
Acronym
P&R
IRCT registration information
IRCT registration number:IRCT20211031052921N1
Registration date:2022-12-19, 1401/09/28
Registration timing:registered_while_recruiting
Last update:2022-12-19, 1401/09/28
Update count:0
Registration date
2022-12-19, 1401/09/28
Registrant information
Name
Mahnaz Dastyarkohan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3824 8499
Email address
dastyarkohanmahnaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-02-09, 1401/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of plasmalite A and lactate ringer in prime solution on acid and base status and electrolytes)Na.K.Ca)and lactate level and blood sugure in people with Diabet undergoing cardiac surgery with cardiopulmonary bypass
Public title
Comparison effect of plasmalite A and lactate ringer in prime solution on acid and base status and electrolytes)Na.K.Ca)and lactate level and blood sugure in people with Diabet undergoing cardiac surgery with cardiopulmonary bypass at Rajaei Cardiovascular Center
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 17 years
Elective surgeries
The first time of heart surgery (CABG) and valvular surgery
LVEF>30%
Being diabetic
Exclusion criteria:
Creatinine higher than 1.5
Returning to the cardiopulmonary pump for any reason up to 24 hours after the operation
Cardiopulmonary arrest during surgery and cardiopulmonary resuscitation
Back to the operating room on the first day of surgery
Age
From 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
3 Plasmolyte or Ringer's serum of 500 ml for each person
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization
The study participants will be randomly allocated into two groups equally (allocation ratio: 1:1) by the permuted balance block technique (block of 4) and via a web-based application (https://www.sealedenvelope.com). Randomization concealment will be performed by using the sealed envelope method. The prepared envelopes will be given to the study PI for appropriate implication. All of the mentioned processes will be performed by one of our colleagues who doesn’t involve in implementing the intervention and outcome assessment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant, who is a volunteer to participate in this study, is informed about the two types of serum received, but he does not know which type of serum will be primed, and the clinical supervisor of the outcome is similarly unaware of the type of serum received for prime, and is completely far from pre-determined judgment. He is overseeing the affairs
Placebo
Used
Assignment
Factorial
Other design features
مطالعه بر روی افراد دیابتی فقط انجام میشود
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rajaei Hospital
Street address
Tehran Province, Tehran District 3, Valiasr Street, Hashemi Rafsanjani Hwy, No. At the beginning, 11151 19969 Niayesh Corner of Shahid Rajaei Cardiovascular Training, Research and Treatment Center
City
tehran
Province
Tehran
Postal code
1995614331
Approval date
2022-05-14, 1401/02/24
Ethics committee reference number
IR.RHC.REC.1401.014
Health conditions studied
1
Description of health condition studied
diabet
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Electrolytes (sodium, potassium, calcium) in the blood
Timepoint
Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar levels are considered.
Method of measurement
The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form
2
Description
Blood lactate level
Timepoint
Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar le
Method of measurement
The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form
3
Description
blood sugar
Timepoint
Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar levels
Method of measurement
The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form
4
Description
Acid and base conditions
Timepoint
Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar levels
Method of measurement
The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form
Secondary outcomes
1
Description
Blood hemoglobin level
Timepoint
Arterial blood samples are evaluated before the start of CPB, after the start of CPB, then every hour until the end of the procedure, and then upon entering the ICU, and after that at 6, 12, 18, and 24 hours. The blood sample is taken using a Technomedia blood gas analyzer
Method of measurement
Hemoglobin level is also checked using an arterial blood sample which is a blood cell count check
Intervention groups
1
Description
The intervention group includes people receiving plasmolyte serum, which is prepared by Saman Mashhad company and is used for the prime of the cardiopulmonary bypass device of the patients under study, and in terms of osmolality, it is the most similar serum to the patient's blood. And for each patient, there are about three serums. One liter of plasmolite is used
Category
N/A
2
Description
Control group: The recipients of Ringer's lactate serum are considered to be recipients. About three one-liter Ringer's lactate serums are used for the prime of the cardiopulmonary bypass machine for volunteers. Its osmolarity is 280 and it is available in large numbers in Iran in recent years.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaei hospital
Full name of responsible person
Rasool Azarfarin
Street address
Tehran Province, Tehran District 3, Valiasr Street, Hashemi Rafsanjani Hwy, No. At the beginning, 11151 19969
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 921 248 3155
Email
dastyarkohanmahnaz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Rajaei Heart and Vascular Hospital Research Center
Full name of responsible person
Rasool Azarfarin
Street address
Tehran Province, Tehran District 3, Valiasr Street, Hashemi Rafsanjani Hwy, No. At the beginning, 11151 19969
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2204 2026
Email
dastyarkohanmahnaz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaei Heart and Vascular Hospital Research Center
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
Shahid Rajaee Heart and Vascular Hospital's Medical Research Training Center
Full name of responsible person
rasoolazarfarin
Position
professor
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran Province, Tehran District 3, Valiasr Street, Hashemi Rafsanjani Hwy, No. At the beginning, 11151 19969
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2204 2026
Email
dastyarkohanmahnaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
the university of iran.rajaei hospital
Full name of responsible person
Dr Rasool Azarfarin
Position
Anesthsiologist Proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Nursery
Street address
Tehran Province, Tehran District 3, Valiasr Street, Hashemi Rafsanjani Hwy, No. At the beginning, 11151 19969
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 71 3824 8499
Email
dastyarkohanmahnaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Rajaei educational research and treatment center
Full name of responsible person
Dr Rasool Azarfarin
Position
Anesthesiologist Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran Province, Tehran District 3, Valiasr Street, Hashemi Rafsanjani Hwy, No. At the beginning, 11151 19969
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
23921-021
Email
razarfarin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The informed consent form is available to all participants in the study, and all of them can be informed about the type of substance they have received. The clinical report is attached as a document after the completion of the work and the result
When the data will become available and for how long
All information will be available in the second half of 1402
To whom data/document is available
People participating in the study if interested
Clinical supervisors
The researcher and all the people who somehow contributed to the progress of the study
Under which criteria data/document could be used
In the form of a thesis and a written file in the library of Rajaei Hospital
From where data/document is obtainable
To the curator of Rajaei hospital library
What processes are involved for a request to access data/document
This possibility of access is provided by visiting the library of Rajaei Hospital in person