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IRCT20190929044923N1 IRCT 2021-01-16 Tehran University of Medical Sciences A Comparison of the effects of amiodarone and osmolol in patients with septic shock A comparison of the effects of Heart Rate Control with Amiodarone and esmolol on Hemodynamic and Clinical Outcomes in Patients with Septic Shock 2019-12-22 anticipated 30 Complete https://irct.ir/trial/52225 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 septic shock. Intervention 1: Intervention group: The first intervention included amiodarone group therapy: After measuring the patient's hemodynamic characteristics, cardiac output, vascular resistance by uscom, patients are treated with amiodarone. The dose of amiodarone in these patients according to Guidalin is 150 ACC / AHA mg for 10 minutes and then infusion of 1-0.5 mg / minute. The dosage of this drug is adjusted so that patients are divided into the following groups based on heart rate. - If the heart rate is more than 100 beats per minute, continuous infusion of 1 mg / minute is started. - If the heart rate is more than 90 beats and less than 100 beats per minute, continuous infusion of 0.5 mg / min is started. If the target heart rate is not reached, it is increased by 1 mg / min every 20 minutes. If it is more than 70 times and less than 80 times per minute, the infusion is reduced to 0.5 mg per minute. - If the heart rate is more than 60 times and less than 70 times per minute, the infusion is 1 mg / minute. Intervention 2: Control group: esmolol treatment control group: In this group, after measuring the patient's hemodynamic characteristics, cardiac output, vascular resistance by uscom device, patients are treated with esmolol. The goal is a heart rate of 85 beats per minute. The esmolal dose of the infusion in these patients is 20 μg / kg / min. The dosage of this drug is adjusted in such a way that patients are divided into the following groups based on heart rate. - If the heart rate is more than 100 beats per minute, it starts with 20 μg / kg / min. - If the heart rate Start between 100-90 times per minute esmolol starts at a dose of 10 μg / kg / min. - If the target heart rate is not reached, it will increase by 20 micrograms / kg every 20 minutes. If the heart rate is between 80-70 beats per minute, the infusion is reduced to 10 μg / kg / min. If the heart rate is between 70-60 beats per minute, the infusion is reduced to 20 μg / kg / min. If the following is observed, the infusion of esmolol is stopped: - If the heart rate drops below 60: The infusion is stopped for 20 minutes and then continues with an increase in heart rate above 70 beats per minute at half the previous speed . ScvO2 ≤ 60% OR LV ejection fraction ≤ 25% OR Cardiac Index ≤ 2.0 L / min / m2 - In case of bronchospasm, the drug is permanently discontinued and It does not start again. Yes - There is a plan to make this available What will be shared: The raw data obtained from this study, an an excel or SPSS file will be provided to them at the request of the project supervisor or the reviewer of the article When: After writing the initial draft of the article To whom: project supervisor or the reviewer of the article upon their request Conditions: If re-analyis of the data is needed Where to obtain: Written correspondence with the first executor of the project How to obtain: Written correspondence with the first executor of the project if necessary to re-analyze the data Comments:
public masood khataminia
sina hospital emem khomeini street , hasan abad
tehran Iran (Islamic Republic of) ١١٣٦٧٤٦٩١١ +98 21 6634 8500 masoodkhataminia@yahoo.com Tehran University of Medical Sciences scientific masoud khataminia
sina hospital , emam khomeini street, hassan abad
tehran Iran (Islamic Republic of) ١١٣٦٧٤٦٩١١ 021ر66348500 masoodkhataminia@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) septic shock receiving vasopressor despite adequate fluid therapy Heart rate above 100 beats per minute for no apparent reason (such as fever, agitation, pain, anemia, and hypovolemia that should be treated before starting medication and hemodynamic tests) Cardiac index above 2.5 liters / minute per square meter Absence of arrhythmia 18 years no limit Both treatment with beta-blocker or amiodarone in the last 48 hours Patient with heart valve problems Pregnancy Pulmonary fibrosis Hypo / Hyperthyroidism Known pulmonary hypertension History of amiodarone intolerance Post CPR conditions Aortic aneurysm ARDS with PaO2 / FiO2 less than 150 A41.9 Sepsis, unspecified organism Treatment - Drugs Treatment - Drugs Intervention group: The first intervention included amiodarone group therapy: After measuring the patient's hemodynamic characteristics, cardiac output, vascular resistance by uscom, patients are treated with amiodarone. The dose of amiodarone in these patients according to Guidalin is 150 ACC / AHA mg for 10 minutes and then infusion of 1-0.5 mg / minute. The dosage of this drug is adjusted so that patients are divided into the following groups based on heart rate. - If the heart rate is more than 100 beats per minute, continuous infusion of 1 mg / minute is started. - If the heart rate is more than 90 beats and less than 100 beats per minute, continuous infusion of 0.5 mg / min is started. If the target heart rate is not reached, it is increased by 1 mg / min every 20 minutes. If it is more than 70 times and less than 80 times per minute, the infusion is reduced to 0.5 mg per minute. - If the heart rate is more than 60 times and less than 70 times per minute, the infusion is 1 mg / minute. Control group: esmolol treatment control group: In this group, after measuring the patient's hemodynamic characteristics, cardiac output, vascular resistance by uscom device, patients are treated with esmolol. The goal is a heart rate of 85 beats per minute. The esmolal dose of the infusion in these patients is 20 μg / kg / min. The dosage of this drug is adjusted in such a way that patients are divided into the following groups based on heart rate. - If the heart rate is more than 100 beats per minute, it starts with 20 μg / kg / min. - If the heart rate Start between 100-90 times per minute esmolol starts at a dose of 10 μg / kg / min. - If the target heart rate is not reached, it will increase by 20 micrograms / kg every 20 minutes. If the heart rate is between 80-70 beats per minute, the infusion is reduced to 10 μg / kg / min. If the heart rate is between 70-60 beats per minute, the infusion is reduced to 20 μg / kg / min. If the following is observed, the infusion of esmolol is stopped: - If the heart rate drops below 60: The infusion is stopped for 20 minutes and then continues with an increase in heart rate above 70 beats per minute at half the previous speed . ScvO2 ≤ 60% OR LV ejection fraction ≤ 25% OR Cardiac Index ≤ 2.0 L / min / m2 - In case of bronchospasm, the drug is permanently discontinued and It does not start again. Stroke volume index. Timepoint: 0,6,12,24 hour after adminstration. Method of measurement: uscom. Cardiac output index. Timepoint: 0 612 24 hours after adminstration. Method of measurement: uscom. Heart rate. Timepoint: 0 6 12 24 hours after adminstration. Method of measurement: heart rate monitoring device. Vascular resistance. Timepoint: 0, 6 12 24 after adminstration. Method of measurement: uscom. Acid lactic. Timepoint: baseline and 24hours after administration. Method of measurement: laboratory analysis. Mean arterial pressure. Timepoint: 0, 6 12 24 after adminstration. Method of measurement: monitoring device. Vasopressor intake rate. Timepoint: 0, 6 12 24 after adminstration. Method of measurement: View Cardex. The amount of fluid received. Timepoint: baseline and 24hours after administration. Method of measurement: View Cardex. Tehran University of Medical Sciences Approved 2019-07-23 Vice Chancellor for Research and Technology, Tehran University of Medical Sciences Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology tehran Tehran Iran (Islamic Republic of)