Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT01830920
Eligibility Criteria:
Inclusion Criteria:
* Male or female and \>18 years of age.
* Scheduled for a non-emergent coronary and/or valve surgery procedure requiring CPB, to include:
* coronary artery bypass graft (CABG) alone;
* aortic valve replacement or repair alone, with or without aortic root repair;
* mitral, tricuspid, or pulmonic valve replacement or repair alone;
* simultaneous replacement of several cardiac valves;
* CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair;
* CABG with combined cardiac valve replacement or repair.
* Have the following risk factors for CSA-AKI:
* eGFR ≥ 20 and \< 30 ml/min/1.73m2 OR
* eGFR ≥ 30 and \< 60 ml/min/1.73m2 and ONE of the following additional risk factors (other than age ≥ 75 years) OR
* eGFR ≥ 60 ml/min/1.73m2 and TWO of the following additional risk factors
Additional Risk Factors:
* Age ≥ 75 years;
* Combined valve \& coronary surgery;
* Previous cardiac surgery with sternotomy;
* Documented NYHA Class III or IV within 1 year prior to surgery;
* Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive diagnostic cardiac imaging - echocardiography, nuclear imaging, computed tomography, magnetic resonance imaging or angiography performed within 90 days prior to surgery. (If LVEF ≤ 35% by any invasive or noninvasive imaging procedure, patient meets the risk factor.)
* Insulin-requiring diabetes;
* Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (medical history or dipstick);
* Preoperative anemia (hemoglobin \<11g/dl for men and women).
Exclusion Criteria:
If any of the following criteria apply prior to surgery, the patient will be excluded from the study:
* Age \> 85 years;
* Weight \>174 kg or 383 lbs;
* The presence of AKI (KDIGO criteria) at the time of screening ;
* Surgery to be performed without CPB;
* Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \< 28°Celsius (82.4° Fahrenheit);
* eGFR (MDRD) \<20 ml/min/1.73m2;
* Surgery for aortic dissection;
* Surgery to correct a major congenital heart defect (e.g., Tetralogy of Fallot, transposition of the great vessels, single ventricle, Ebsteins anomaly. Bicuspid aortic valve is not to be considered a congenital heart defect.);
* Prior organ transplantation;
* Dialysis-dependence;
* Administration of iodinated contrast media within 24 hours prior to cardiac surgery;
* If received contrast media prior to 24 hours and have AKI as defined by KDIGO criteria;
* Cardiogenic shock or haemodynamic instability within the 24 hours prior to surgery, including the anesthesia induction period; as defined by a systolic BP \<80 mm Hg and pulse \>120 beats per minute (bpm) and requirement for inotropes or vasopressors or other mechanical devices such as intra-aortic balloon counter-pulsation (IABP);
* Requirement for any of the following within seven (7) days prior to cardiac surgery:
* defibrillator or permanent pacemaker,
* mechanical ventilation,
* intra-aortic balloon counter-pulsation (IABP),
* left ventricular assist device (LVAD),
* other forms of mechanical circulatory support (MCS);
* Cardiopulmonary resuscitation within 14 days prior to cardiac surgery;
* Known history of cancer within the past 5 years, except for carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin;
* Known or suspected sepsis at time of screening;
* Known or suspected glomerulonephritis or interstitial nephritis at time of screening;
* Confirmed or treated endocarditis within previous 30 days prior to cardiac surgery;
* Other current active infection requiring antibiotic treatment;
* Patients with known active human immunodeficiency virus infection;
* Documented history of HIV antibodies;
* Patients with known active Hepatitis B (HBV) or Hepatitis C (HCV) infection;
* Documented history of HCV antibodies;
* Documented history of HBV antigens;
* Patients on immunosuppressant drugs or prednisone over the dose of 20 mg per day;
* Inadequate hepatic function, defined as total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of normal (ULN) at time of screening or Child Pugh Class C liver disease ( see appendix 6) or higher;
* Any congenital coagulation disorder;
* Pregnancy or lactation;
* If patient has "Do Not Resuscitate" (DNR) status;
* Known hypersensitivity to the study drug or any of its excipients;
* Treatment with an investigational drug or participation in an interventional trial within 60 days prior to 1st dose of study drug;
* In the opinion of the investigator any disease processes or confounding variables that would inappropriately alter the outcome of the study;
* Inability to comply with the requirements of the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01830920
Study Brief:
Protocol Section:
NCT01830920