Status:
COMPLETED
Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery
Lead Sponsor:
Rajaie Cardiovascular Medical and Research Center
Collaborating Sponsors:
Heart Valve Disease Research Center
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
In this randomized clinical trial, patients with undergoing open heart valve surgery will be enrolled into the study. Participants will be divided into two groups based on the priming solution type. T...
Detailed Description
Cardiopulmonary bypass (CPB) pump is a device for circulating blood in the body while the heart is undergone surgery. For providing circulating volume in the body we need to add about 1.5 to 2 lit flu...
Eligibility Criteria
Inclusion
- patients who provided written informed consent and had no heart failure (LVEF \>55%), no hepatic failure (defined as aspartate aminotransferase (AST) \>40 mg/dL and/or alanine aminotransferase (ALT) \>40 mg/dL), no prior history of cardiac surgery, serum creatinine \<1.5 mg/dL, no episode of drug-induced acute kidney injury within preoperative 5 days, no severe carotid stenosis in both or one of them, no emergency valvular stenosis, no infective endocarditis, no severe right ventricular failure, no hemoglobin \<10 mg/dL, no body mass index \>40 kg/m2, no heparin-induced thrombocytopenia, no cancer, no severe pulmonary valve insufficiency, no pulmonary function test \<65% before heart valve surgery
Exclusion
- included consent withdrawal by the patient or by his/her proxy, allergic reaction to the drugs, the aortic cross clamp time greater than 120 minutes, on-pump time greater than 150 minutes, the performance of the retrograde autologous priming.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05223361
Start Date
April 1 2016
End Date
November 30 2021
Last Update
February 3 2022
Active Locations (1)
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1
Rajaie CMRC
Tehran, Iran