EUCTR2018-004871-11-DE进行中（未招募）1 期
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATION STUDY OF ULARITIDE FOLLOWED BY A 42-HOUR INFUSION FOR THE TREATMENT OF ACUTE KIDNEY INJURY (AKI) IN PATIENTS POST CARDIAC SURGERY - TRUST
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and post-menopausal female patients of = 18 years. Post-menopause is defined as = 12 months after the last menstruation without an alternative medical cause
- •2. Body mass index = 35 kg/m2
- •3. Decrease of post-surgery GFR-1h-Crea measured twice approximately 1 hour apart within the first 3 hours post-surgery =50% compared to pre-surgery eGFR (CKD-EPI)
- •4. Index hospitalization for planned cardiac surgery via open sternotomy on cardiopulmonary bypass namely coronary artery bypass graft, valve surgery, thoracic aortic surgery, repair of ventricular septal defect or a combination thereof
- •5. Preoperative predictive score for cardiac surgery-associated AKI of 3 or higher according to Jiang et al., 201615
- •6. Hemodynamic stability defined as:
- •a. Systolic blood pressure (SBP) >90 mmHg in at least two consecutive non-invasive measurements that are at least 60 minutes apart in a 2-hour time window immediately post-surgery
- •b. No increase in vasopressor and/or inotropic support at the end of a 2-hour time window immediately post-surgery compared to its start
- •7. Signed written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Documented medical history of renal artery stenosis (=70%), nephrotic syndrome, renal sclerosis
- •2. Clinical diagnosis of
- •a. Severe cardiogenic shock (INTERMACS level I) or extracorporal membrane oxygenation, or any other short-term pre-surgery mechanical circulatory support other than intra-aortal balloon pump
- •b. Right ventricular infarction
- •3. Body temperature >38.0°C on the day before surgery
- •4. Patients started on dialysis prior to surgery or immediately thereafter
- •5. Pre-surgery eGFR (CKD-EPI) <60 mL/min/1.73 m2 based on serum concentrations of creatinine and cystatin C
- •6. Treatment with sacubitril-valsartan from the day before surgery until 60 hours post infusion start
- •7. Advanced cancer or any other acute or chronic consuming disease which could relevantly interfere with the surgery outcome (survival) or success of test treatments
- •8. Known hypersensitivity to the active substance or to any of the excipients of each investigational medicinal product (verum and placebo) or other natriuretic peptides
- •9. Known Hepatitis B or C or HIV infection
- •10. Participation in an interventional clinical drug trial within 1 month prior to randomization
- •11. Legal incapacity or limited legal capacity
- •12. Breastfeeding or pregnancy
- •13. Employees of the sponsor or patients who are employees or relatives of the investigator
- •14. Patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
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