Status:
WITHDRAWN
Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot randomized-controlled study will determine the feasibility of large study comparing individualized versus standard blood pressure (BP) management in patients undergoing cardiac surgery unde...
Detailed Description
Adequate hemodynamic control is a cornerstone in management in patients undergoing different types of surgery. Among all perioperative risk factors, the association between perioperative hypotension a...
Eligibility Criteria
Inclusion
- ≥18 years old
- Signed informed consent
- Elective cardiac surgery under CPB (CABG or valve surgery)
Exclusion
- Unstable Coronary Artery Disease: Recent (\< 6 weeks) myocardial infarction, unstable angina, severe (\> 70%) left main coronary artery stenosis
- Uncontrolled hypertension preoperatively (SBP \> 160 mm Hg)
- Critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or intraaortic balloon pumping, preoperative severe acute renal failure (anuria or oliguria \<10ml/hr)
- Planned surgery on aorta
- Emergency surgery
- Pregnancy
- Current enrollment into another randomized controlled trial (in the last 30 days)
- Previous enrollment and randomization into current study
- Glomerular filtration rate ≤59 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03784690
Start Date
January 21 2019
End Date
April 10 2020
Last Update
November 22 2019
Active Locations (1)
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1
Meshalkin Research Institute of Pathology of Circulation
Novosibirsk, Russia, 630055