Status:
COMPLETED
Prevention of Renal Failure by Nitric Oxide in Prolonged Cardiopulmonary Bypass.
Lead Sponsor:
Xijing Hospital
Conditions:
Heart Valve Diseases
Heart; Complications, Valve, Prosthesis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion of nitric oxide (NO) duri...
Detailed Description
Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion of nitric oxide (NO) duri...
Eligibility Criteria
Inclusion
- Provide written informed consent
- Are \> 18 years of age
- Elective cardiac or aortic surgery with CPB, when the surgeon plans double valve replacement.
- Stable pre-operative renal function, without dialysis.
Exclusion
- Emergent cardiac surgery
- Life expectancy \< 1 year
- Hemodynamic instability as defined by a systolic blood pressure \<90 mmHg
- Administration of ≥1 Packed Red Blood Cell transfusion in the week before surgery
- X-ray contrast infusion less than 1 week before surgery
- Anticipate administration of nephrotoxic agents, such as hydroxyethyl starch
- Evidence of intravascular or extravascular hemolysis
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT01802619
Start Date
August 1 2013
End Date
June 1 2016
Last Update
February 13 2018
Active Locations (1)
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1
Xijing Hospital
Xi'an, Shaanxi, China, 710032