Valvular heart disease,aortic aneurysm,aortic dissection,coronary artery disease Cardiovascular surgery ,cardiopulmonary bypass,hemolysis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who undergo cardiovascular surgery required cardiopulmpnary bypass 2.Patients aged 20 years or older 3.Patients who have given written consent to participate in this study 4.Patients with a free hemoglobin concentration of more than 50 mg/dL within 2 hours of starting cardiopulmonary bypass
Exclusion criteria
Exclusion criteria: 1.Patients who had already had renal replacemt therapy 2.Patients with a preoperative serum creatinine level of 2 mg/dl or higher 3.Patients scheduled for surgery involving the descending aorta 4.Patients who undergoing MICS (Minimum Invasive Cardiac Surgery) 5.Patients with haptoglobin deficiency 6.Patients with IgA deficiency 7.Patients with hepatic impairment(Bil>2.0mg/dL) 8.Patients with hemolytic diseases(Autoimmune haemolytic anaemia, paroxysmal nocturnal haemoglobinuria, hereditary spherocytosis, etc.) 9.Immunocompromised and immunosuppressed patients(e.g. patients on immunosuppressive drugs or who have used chemotherapeutic drugs for malignancy within the last year) 10.Patients who are deemed inappropriate by the study investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference between a preoperative creatinine level and a maximum creatinine level within 48 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| (Efficacy Outcomes) 1.Perioperative free hemoglobin concentration at each measurement point 2.Perioperative serum haptoglobin concentration at each measurement point 3.Postoperative creatinine level at each measurement point and Incidence of postoperative renal failure(AKIN classification) 4.Perioperative renal function markers at each measurement point 5.Perioperative methemoglobin concentration at each measurement point 6.Presence and extent of postoperative organ injury (Safety Outcomes) Disease during the observation period Incidence of complications (Expolatory Outcome) Perioperative NO concentration at each measurement point | — |
Contacts
Kobe University Hospital