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IRCT20211031052921N1 IRCT 2022-12-19 Shahid Rajaei Heart and Vascular Hospital Research Center 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 P&R 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 2022-12-11 anticipated 60 Complete https://irct.ir/trial/66242 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Other design features: مطالعه بر روی افراد دیابتی فقط انجام میشود, 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 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. 3 diabet. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public rasoolazarfarin
Tehran Province, Tehran District 3, Valiasr Street, Hashemi Rafsanjani Hwy, No. At the beginning, 11151 19969
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2204 2026 dastyarkohanmahnaz@gmail.com Shahid Rajaee Heart and Vascular Hospital's Medical Research Training Center scientific Dr Rasool Azarfarin
Tehran Province, Tehran District 3, Valiasr Street, Hashemi Rafsanjani Hwy, No. At the beginning, 11151 19969
Tehran Iran (Islamic Republic of) 1995614331 +98 71 3824 8499 dastyarkohanmahnaz@gmail.com the university of iran.rajaei hospital Iran (Islamic Republic of) Age above 17 years Elective surgeries The first time of heart surgery (CABG) and valvular surgery LVEF>30% Being diabetic 17 years no limit Both 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 E11 Type 2 diabetes mellitus N/A N/A 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 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. 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. 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. 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. 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. 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. Shahid Rajaei Heart and Vascular Hospital Research Center Approved 2022-05-14 Ethics Committee of Rajaei Hospital 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 tehran Tehran Iran (Islamic Republic of)