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IRCT20230915059434N1 IRCT 2023-10-14 Shaheed Rajaie Cardiovascular Medical and Research Center The Effect of Vacuum Assisted Venous Drainage (VAVD) on Kidney Function and Blood Transfusion The Effect of Vacuum Assisted Venous Drainage on Kidney Function and Blood Transfusion in Patients Undergoing Cardiac reoperation 2023-11-01 anticipated 90 Complete https://irct.ir/trial/72713 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be divided into two groups using a random block method with a size of 6: 45 patients in the VAVD group (receiving VAVD during cardiopulmonary bypass) and 45 patients in the GD group (venous drainage with gravity only), Blinding description: After obtaining informed consent, due to being under anesthesia and surgery, the patients will not know whether they will be assigned to the control or intervention group and ICU nurses will not know about the use or non use of VAVD during cardiopulmonary bypass. N/A Cardiac reoperation. Intervention group: In the intervention group, by using the Polystan VAVD Controller and reducing the height difference between the patient and the venous reservoir, the length of the cardiopulmonary bypass circuit lines will be reduced to reduce the volume of the primary bypass circuit by 250 cc. Throughout the use of Vacuum Assisted Venous Drainage(VAVD), the negative pressure of the venous reservoir will be monitored and controlled in the range of -30 to -45 mm Hg.. Yes - There is a plan to make this available What will be shared: All information related to the study procedure and its consequences can be provided When: After publishing the articles from the study, the data will be available. To whom: All researchers in the field of medical sciences Conditions: With scientific purposes and with the author's knowledge Where to obtain: To access the data, you can contact the researcher Zahra Majidi via e-mail zahra.majidiparizi@gmail.com and the address of Tehran, Shaheed Rajaie Heart Hospital. How to obtain: After communicating with the researcher via email or address and fully introducing the applicant and stating the purpose of using the data, it will be possible to access the data in less than a month. Comments:
public Zahra Majidi Parizi
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 zahra.majidiparizi@gmail.com Shaheed Rajaie Cardiovascular Medical and Research Center scientific Zahra Majidi Parizi
Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection
Tehran Iran (Islamic Republic of) 1995614331 +98 21 23921 zahra.majidiparizi@gmail.com Shaheed Rajaie Cardiovascular Medical and Research Center Iran (Islamic Republic of) Patients who are candidates for cardiac reoperation Informed consent to participate in the study Age more than 18 years (Left Ventricular Ejection Fraction) LVEF greater than 35% 18 years no limit Both Presence of large vessel surgeries requiring Deep Hypothermic Circulatory Arrest (DHCA), third time reoperation and more Presence of kidney failure before surgery (patient with previous diagnosis of kidney failure or creatinine higher than 1.5 mg/dL) Presence of History of bleeding disorders before surgery Presence of Anemia before surgery (hemoglobin less than 10 gr/dL) Presence of history of cerebrovascular diseases Prevention Intervention group: In the intervention group, by using the Polystan VAVD Controller and reducing the height difference between the patient and the venous reservoir, the length of the cardiopulmonary bypass circuit lines will be reduced to reduce the volume of the primary bypass circuit by 250 cc. Throughout the use of Vacuum Assisted Venous Drainage(VAVD), the negative pressure of the venous reservoir will be monitored and controlled in the range of -30 to -45 mm Hg. Serum creatinine level. Timepoint: Preoperatively, upon admission to the intensive care unit, 24 and 48 hours later. Method of measurement: laboratory test. Blood Urea Nitrogen. Timepoint: Preoperatively, upon admission to the intensive care unit, 24 and 48 hours later. Method of measurement: laboratory test. The amount of urinary output. Timepoint: During cardiopulmonary bypass, 6, 12, 24 and 48 hours after surgery. Method of measurement: Patient file information. Central Venous Pressure. Timepoint: Before starting bypass, During and after the completion of cardiopulmonary bypass, upon entering the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: Patient monitoring information. Mean Arterial Pressure. Timepoint: Before starting bypass, During and after the completion of cardiopulmonary bypass, upon entering the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: Patient monitoring information. Prime volume used in cardiopulmonary bypass circuit. Timepoint: The volume of fluid used in the circuit at the start of cardiopulmonary bypass. Method of measurement: Patient file information. Hemoglobin. Timepoint: Preoperatively, before starting bypass, during and after completion of cardiopulmonary bypass, upon admission to the intensive care unit, 6, 12, 24, and 48 hours after surgery. Method of measurement: laboratory test. The amount of blood transfusion. Timepoint: Up to 48 hours after surgery. Method of measurement: Patient file information. Shaheed Rajaie Cardiovascular Medical and Research Center Approved 2023-08-05 Research Ethics Committees of Rajaie Cardiovascular Medical and Research Center Shaheed Rajaie Cardiovascular Medical and Research Center, Valiasr Ave, Niayesh Intersection Tehran Tehran Iran (Islamic Republic of)