]>
IRCT20201025049139N1 IRCT 2021-01-15 Tehran University of Medical Sciences midodrine effectiveness in patients who have low mean atrial pressure after open heart surgery randomized clinical trial of midodrine effectiveness in patients who underwent open heart surgery and after surgery their mean atrial blood pressure is low despite receiving at least 24 hours intravenous inotrope in Tehran Heart Center in 1399 to 1400 2020-10-31 anticipated 100 Complete https://irct.ir/trial/51925 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Case and control groups are randomized with statistical software (excel), patients who have entrance criteria enter to trial by ICU physician who visit patients every day. After entrance one of ICU nurses divided patients to two groups (A and B) according above list. after division the ICU drug responsible give the patients midodrine or placebo according A or B group, Blinding description: Patients who visited with ICU physician and have entrance criteria, enter to the study.After that one of nurses according to the list that made by software divide patients to two groups, A and B. According A or B, the nurse give patients A or B drugs. Nurse don't know which one is drug and which one is placebo. All information gather with resident. 3 CABG. Intervention 1: Intervention group: we prescribe midodrine 5 mg every 12 hours, after IV inotrope discontinuation we change the dose to 2.5 mg every 12 hours an after 3 days discontinue midodrine. Intervention 2: Control group: we prescribe placebo to this group and after IV inotrope discontinuation we continue placebo half dose and after 3 days we discontinue it. Yes - There is a plan to make this available What will be shared: All data will publish after trial without patient's name. When: 6 months after publishing data until unlimited time To whom: All researchers Conditions: All conditions Where to obtain: mostafa_zia@yahoo.com k-hosseinu@tums.ac.ir How to obtain: send his or her request to above E-mails, in one week we answer the request Comments:
public Mostafa Ziaoddini
Amir abad, North karegar, Tehran Heart Center
Tehran Iran (Islamic Republic of) 0123456789 +98 34 3212 1088 mostafa_zia@yahoo.com Tehran University of Medical Sciences scientific Mostafa Ziaoddini
Amir abad, North karegar, Tehran Heart Center
Tehran Iran (Islamic Republic of) 0123456789 +98 34 3212 1088 mostafa_zia@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) More than 18 years old Admitted in ICU Systolic blood pressure less than 90 mmHg or mean atrial pressure less than 80 mmHg Dependent to IV vassopressor Received at least 24 hours IV vassopressor and can not discontinue it Operation type is CABG 18 years no limit Both hypovolemia septic shock kidney failure (Cr>2mg/dl) hepatic failure electrolyte disturbance pregnancy tamponed active bleeding hypothyroid hyperthyroid midodrine allergy I25.701 Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm Treatment - Drugs Placebo Intervention group: we prescribe midodrine 5 mg every 12 hours, after IV inotrope discontinuation we change the dose to 2.5 mg every 12 hours an after 3 days discontinue midodrine Control group: we prescribe placebo to this group and after IV inotrope discontinuation we continue placebo half dose and after 3 days we discontinue it Blood pressure dependency rate to IV inotrope after midodrine initiation. Timepoint: study entrance time and 48 hours after that. Method of measurement: with Sphygmomanometer. Intravenous vasopressor dose. Timepoint: after intravenous vasopressor discontinuation. Method of measurement: microgram. ICU length of stay. Timepoint: after patient discharge from ICU. Method of measurement: according to hour. Hospital length of stay. Timepoint: after patient discharge. Method of measurement: according to hour. Left ventricular function. Timepoint: at the time of randomization. Method of measurement: echocardiography. Creatinine. Timepoint: at the time of randomization. Method of measurement: in lab. Tehran University of Medical Sciences Approved 2020-09-14 Ethics committee of Tehran University of Medical Sciences Tehran Heart Center, North Karegar, Amir Abad, Tehran Tehran Tehran Iran (Islamic Republic of)