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IRCT20130304012695N5 IRCT 2020-07-04 Tehran University of Medical Sciences The effect of bicarbonate in increasing blood pressure in patients with hemorrhagic shock Evaluation of hemodynamic effects of bicarbonate infusion in hemorrhagic shock 2019-06-22 anticipated 40 Complete https://irct.ir/trial/48508 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize patients with inclusion criteria Block balanced randomization is used.Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group. The complete cards of the four blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room, Blinding description: The patient is unaware of the type of intervention. 2-3 Condition 1: hemorrhagic shock. Condition 2: Acidosis. Intervention 1: Intervention group: Patients who has blood loss more than 500 cc during surgery within 20 minutes and have a systolic blood pressure less than 100 mm Hg, sodium bicarbonate infusion started at a rate of 5 cc / minute intravenously and continue until the systolic blood pressure reaches 100 mm Hg,then reduce the rate of bicarbonate to 2 cc/ minute.If the bleeding increases to the tolerable limit level , in each patient transfusion is started .At the end of the transfusion and stop the bleeding, a blood sample is sent to measure blood gases and lactic acid in the blood. Intervention 2: Control group: Patients who has blood loss more than 500 cc during surgery within 20 minutes and have a systolic blood pressure less than 100 mm Hg, Serum Ringer infusion starts at 15 ml / min. If the pressure does not rise after 10 minutes, the Nor adrenaline infusion begins.If the bleeding increases to the tolerable limit level in each patient, transfusion will start .At the end of the transfusion and stop the bleeding, a blood sample is sent to measure blood gases and lactic acid in the blood. Yes - There is a plan to make this available What will be shared: All information used for this research can be shared after unidentified the identity of patients. Also, statistical information, information analysis, study method, findings and conclusions can be shared. When: Starting access after accepting by a valid scientific journal and publishing it To whom: For academic researchers and in the field of science Conditions: All researchers can use all published material and if all or part of this research is published by other people, the name and source of this research and its researchers should be mentioned. Where to obtain: Dr. Mohammad Reza Khajavi Email: khajavim@tums.ac.ir How to obtain: The applicant can request the type of files by email. Comments:
public Mohammadreza Khajavi
Sina hospital Imam Khomeini st.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 khajavim@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Reza Khajavi
Sina hospital, Imam khomeni St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 KHAGAVIM@TUMS.AC.IR Tehran University of Medical Sciences Iran (Islamic Republic of) All patients whose bleeding is more than 500 cc systolic blood pressure lower than 100 mm patients with ASA I,II,III who are candidates for orthopedic Hip surgery, neurosurgery, and vascular surgery. patients required to receive blood transfusions, patients with hemorrhagic shock 18 years 70 years Both All patients with liver dysfunction lung disorders such as COPD increased ICP Patients who do not agree to participate in this study R57.1 E87.2 Hypovolemic shock Acidosis Treatment - Drugs Treatment - Drugs Intervention group: Patients who has blood loss more than 500 cc during surgery within 20 minutes and have a systolic blood pressure less than 100 mm Hg, sodium bicarbonate infusion started at a rate of 5 cc / minute intravenously and continue until the systolic blood pressure reaches 100 mm Hg,then reduce the rate of bicarbonate to 2 cc/ minute.If the bleeding increases to the tolerable limit level , in each patient transfusion is started .At the end of the transfusion and stop the bleeding, a blood sample is sent to measure blood gases and lactic acid in the blood. Control group: Patients who has blood loss more than 500 cc during surgery within 20 minutes and have a systolic blood pressure less than 100 mm Hg, Serum Ringer infusion starts at 15 ml / min. If the pressure does not rise after 10 minutes, the Nor adrenaline infusion begins.If the bleeding increases to the tolerable limit level in each patient, transfusion will start .At the end of the transfusion and stop the bleeding, a blood sample is sent to measure blood gases and lactic acid in the blood. Lactic Acidosis. Timepoint: At the end of surgery. Method of measurement: Vein blood sample mg/dl. Blood pressure changes. Timepoint: After the start of bicarbonate or serum at minutes 3-6-9 12-15. Method of measurement: Through the artier line with Lidco device /mmgh. Blood acidosis. Timepoint: At the end of transfusion. Method of measurement: Arterial blood sample. Tehran University of Medical Sciences Approved 2019-06-11 Ethics committee of ،Tehran University of Medical Sciences SinaHospital, ImamKhomeini st. Tehran Tehran Iran (Islamic Republic of)