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IRCT20161127031131N2 IRCT 2021-11-16 Rajaei Cardiovascular Medical and Research Center A comparative study of fluid therapy with Ringer's and Ringer's lactate solution on acid and base status and blood electrolytes in patients with coronary artery bypass graft surgery Comparison of the effect of fluid therapy with Ringer and Ringer lactate solution on acid and base status and blood electrolytes in patients with coronary artery bypass graft surgery 2021-10-23 anticipated 160 Complete https://irct.ir/trial/59560 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are randomly assigned to two equal groups and for random assignment, permuted block randomization with quadruple blocks is used, Blinding description: In this study, the patients areunaware of which group they are in, but the patient's caregivers (physician and nurse) and statistical analyst are aware. In this study, after obtaining the patient's consent, it is explained that in one of the two groups, Ringer serum or Ringer lactate serum is and at the time of serum administration in the operating room, the patient is anesthetized and in the intensive care unit, anesthesia of patient continues and is unaware, and after waking up, the name of the serum is covered with the label that the nurse is under. . 1 Use of Ringer lactate serum. Intervention 1: Intervention group: After applying the principles of randomization and placing the patient in the intervention group and transferring the patient to the operating room, the necessary monitoring is connected and appropriate intravenous access is established. Is injected. Volume of maintenance fluid per hour according to the law 4ml / kg (initial 10 kg weight) 2ml / kg (second 10 kg weight) 1ml / kg (remaining weight), volume correction due to fasting before the patient's operation, blood volume compensation to be removed And inaccessibility of the vascular system, compensation of urinary out put excess in excess of 1 ml / kg/h during surgery and the first 24 hours of patient admission to the ICU with serum ringer lactate. Primary and secondary outcome variables are measured at desired time points. Intervention 2: Control group: In Control group the same volumes of Ringer's solution will be given and the lactate and electrolyte levels measured in same time intervals. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: After the end of the study To whom: Researchers working in academic and scientific institutions Conditions: Use in medical research Where to obtain: razarfarin@yahoo.com How to obtain: Email Comments:
public Rasool Azarfarin
Ayattollah Hashemi Highway, cross valiasr Ave. Shahid Rajai Hospital
Tehran Iran (Islamic Republic of) 19956114331 +98 21 2392 2017 razarfarin@yahoo.com Iran University of Medical Sciences scientific Rasoul Azarfarin
Ayattollah Hashemi Highway, cross valiasr Ave. Shahid Rajai Hospital
Tehran Iran (Islamic Republic of) 19956114331 +98 21 2392 2017 razarfarin@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 1. Age 30 to 70 years - 2.Weight 30 to 100 kg 3. No license for severe kidney or liver disease (creatinine more than 1.5 and liver enzymes more than 2 times normal) 4. Absence of severe heart failure (LVEF> 35%) 30 years 70 years Both 1. Cardiac arrest of the patient during surgery or on the first day in the intensive care unit, 2. Severe postoperative bleeding on the first day (more than 1000 ml) in the intensive care unit 3. The patient returns to the pump for any reason 4. Intra-aortic implantation of a balloon pump or ECMO for any reason 5.Transfer of the patient to the intensive care unit with an open sternum 6. Need for high-dose inotropes (epinephrine or norepinephrine greater than 0.2 micrograms per kilogram of body weight per minute) Treatment - Other Treatment - Other Intervention group: After applying the principles of randomization and placing the patient in the intervention group and transferring the patient to the operating room, the necessary monitoring is connected and appropriate intravenous access is established. Is injected. Volume of maintenance fluid per hour according to the law 4ml / kg (initial 10 kg weight) 2ml / kg (second 10 kg weight) 1ml / kg (remaining weight), volume correction due to fasting before the patient's operation, blood volume compensation to be removed And inaccessibility of the vascular system, compensation of urinary out put excess in excess of 1 ml / kg/h during surgery and the first 24 hours of patient admission to the ICU with serum ringer lactate. Primary and secondary outcome variables are measured at desired time points.. Control group: In Control group the same volumes of Ringer's solution will be given and the lactate and electrolyte levels measured in same time intervals 1.level of lactate. Timepoint: 1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU. Method of measurement: Arterial blood sample and blood gas analyzer. Level of Sodium,. Timepoint: 1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU. Method of measurement: Arterial blood sample and blood gas analyzer. Level of Potasium. Timepoint: 1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU. Method of measurement: Arterial blood sample and blood gas analyzer. Acidose. Timepoint: 1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU. Method of measurement: Arterial blood sample and blood gas analyzer. Level of Bicarbonate. Timepoint: 1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU. Method of measurement: Arterial blood sample and blood gas analyzer. Rajaei Cardiovascular Medical and Research Center Approved 2021-09-21 Shahid Rajaei Cardiovascular Research Center Ayattollah Hashemi Highway, cross valiasr Ave. Shahid Rajai Hospital Tehran Tehran Iran (Islamic Republic of)