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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT05727618
Eligibility Criteria:
Inclusion Criteria:
* age ≥18 years and ≤80 years;
* scheduled for elective cardiopulmonary bypass heart surgery (adult congenital heart disease surgery, coronary artery bypass grafting, valve replacement, valvuloplasty, heart transplantation and aortic surgery);
* Patients who had pulmonary hypertension (Mean pulmonary artery pressure at rest ≥ 25mmhg or pulmonary artery systolic pressure (PASP) ≥ 40mmhg as shown by echocardiography);
* sign informed consent.
Exclusion Criteria:
* use pituitrin or vasopressin before operation;
* Patients who had acute coronary syndrome;
* preoperative use of left ventricular assist devices other than intra aortic balloon - pump (IABP);
* Patients who had liver, thyroid and adrenal diseases, severe lung diseases, diabetes;
* Patients who had preoperative renal insufficiency (The increase of serum creatinine (SCR) within 48 h ≥ 0.3mg/dl (or ≥ 26.5 μ mol/L)； Or it is known or speculated that the increase of SCR in the past 7 days is more than 1.5 times of the basic value; Or 0.5ml/kg urine volume per hour for 6H);
* Patients who had severe carotid artery stenosis, preoperative stroke, mental disorder and other difficult to communicate and cooperate;
* Patients who had peripheral vascular disease, allergy to vasopressin or pituitrin, severe hyponatremia (na+ \< 130 mmol/l), acute mesenteric ischemia, pregnancy, malignant tumors, required ECMO and underwent emergency surgery or reoperation;
* Patients who had participated in other clinical studies in recent 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05727618
Study Brief:
Protocol Section:
NCT05727618