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:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT01758861
Eligibility Criteria:
Inclusion Criteria:
* preoperative risk factors for AKI and scheduled for complex valvular heart operations
* Enrolled criteria for high risk of AKI were patients with more than 2 of bellows: female, serum creatinine \>1.2 mg/dl, preoperative A-fib, GFR \< 60 ml/min, NYHA class IV, HTN, DM, age \> 65 years, peripheral vascular disease.
* Complex valvular heart operations were defined as double-valve surgery, combined valve and coronary artery bypass grafting procedures, Bentall operation, combined mitral valve surgery and tricuspid annuloplasty or reoperation.
Exclusion Criteria:
* Patients with preexisting uncontrolled hypertension (diastolic blood pressure \> 100 mmHg), immunosuppression, history of thromboembolism, malignant disease, seizure, liver dysfunction, renal impairment (serum creatinine \> 2 mg/dL), and drug or alcohol abuse were excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01758861
Study Brief:
Protocol Section:
NCT01758861