NL-OMON48294尚未招募2 期
Phase 2 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of Reltecimod as compared to placebo in addition to standard of care in patients with sepsis-associated acute kidney injury (SA-AKI) - REAKT
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age: 18 up to and including 85 years
- •2. Has either suspected or confirmed diagnosis of abdominal sepsis requiring
- •treatment with parenteral antibiotics and planned or completed surgical
- •(laparotomy or laparoscopy) or interventional radiologic procedures within 24
- •hours of evaluation by medical personnel. Recommended surgical or
- •interventional radiologic procedures be performed with 12 hours of evaluation
- •by medical personnel.
- •* Suspected clinical diagnosis of abdominal infection as evaluated by the
- •attending surgeon including any of the following clinical criteria:
- •- Abdominal pain and/or tenderness
- •- Localized or diffuse abdominal wall rigidity
- •- Any of the following radiologic findings
- •* Free air (Plain film, CT or MRI scans)
- •* Intraabdominal abscess (Ultrasound, CT or MRI scans)
- •* Free peritoneal fluid (Ultrasound, CT or MRI scans)
- •* Confirmed diagnosis of abdominal infection by any of the of the following
- •- Perforation and/or necrotic bowel with surgical confirmation of peritonitis
- •- Presence of intraabdominal abscess by surgical confirmation or drainage of
- •purulent fluid from interventional radiologic procedure
- •3. Age: 18 up to and including 85 years
- •4. Has either suspected or confirmed diagnosis of abdominal sepsis requiring
- •treatment with parenteral antibiotics and planned or completed surgical
- •(laparotomy or laparoscopy) or interventional radiologic procedures within 24
- •hours of evaluation by medical personnel. Recommended surgical or
- •interventional radiologic procedures be performed with 12 hours of evaluation
- •by medical personnel.
- •* Suspected clinical diagnosis of abdominal infection as evaluated by the
- •attending surgeon including any of the following clinical criteria:
- •- Abdominal pain and/or tenderness
- •- Localized or diffuse abdominal wall rigidity
- •- Any of the following radiologic findings
- •* Free air (Plain film, CT or MRI scans)
- •* Intraabdominal abscess (Ultrasound, CT or MRI scans)
- •* Free peritoneal fluid (Ultrasound, CT or MRI scans)
- •* Confirmed diagnosis of abdominal infection by any of the of the following
- •- Perforation and/or necrotic bowel with surgical confirmation of peritonitis
- •- Presence of intraabdominal abscess by surgical confirmation or drainage of
- •purulent fluid from interventional radiologic procedure
- •5. Planned or current admission to a hospital ward (preferably to an ICU but
- •patients admitted to a step down unit (or equivalent) or general ward are also
- •considered eligible)
- •6. Initial diagnosis of AKI established either upon presentation to medical
- •care at the study site in those patients with suspected abdominal sepsis or in
- •those patients in whom the initial diagnosis of AKI is established during the
- •48-hour period from the suspected diagnosis of abdominal sepsis.
- •AKI Stage 2 or 3 according to the following KDIGO AKI criteria:
- •* Stage 2 AKI
- •- Increase in serum creatinine to > 200% (* 2.0*fold) from a reference
- •creatinine value (see below) in the absence of primary underlying renal disease
- •(eGFR>30 ml/min)
- 另有 4 项未显示
排除标准
- •1. Has known prior history of CKD with a documented estimated GFR (eGFR) < 30
- •mL/min by a commonly used formula such as Modification of Diet in Renal Disease
- •(MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or known
- •GFR < 30 mL/min.
- •* Exception: Patients with history of CKD but no available prior eGFR who have
- •documented normal kidney size on ultrasound or computed tomography (normal size
- •defined above) evaluation (performed within 90 days of screening) will be
- •2. Patients receiving RRT for chronic kidney disease: either hemodialysis,
- •peritoneal dialysis, hemofiltration such as Continuous Veno-Venous
- •Hemofiltration (CVVH) or hemodiafiltration.
- •3. Removed
- •4. Previously diagnosed with documented AKI in the last 30 days
- •5. Documented primary glomerular disease or toxic tubulo-interstitial nephritis
- •or other underlying renal diseases significantly effecting renal function
- •(e.g., renal amyloidosis, polycystic kidney disease, renal cancer, renal
- •abscess) at the time of AKI diagnosis
- •6. Current condition of: (a) Inability to maintain a mean arterial pressure >
- •50 mmHg and/or systolic blood pressure > 70 mmHg for at least 1 hour prior to
- •dosing despite the presence of vasopressors and IV fluids or (b) a patient with
- •respiratory failure such that an SaO2 of 80% for at least 1 hour prior to
- •dosing cannot be achieved or (c) a patient with refractory coagulopathy (INR
- •>5) or thrombocytopenia (platelet count <20,000) that does not partially
- •correct for at least 1 hour prior to dosing with administration of appropriate
- •factors or blood products;
- •7. Severe neurological impairment due to cerebrovascular accident or cardiac
- •8. Recent cerebrovascular accident in the last 3 months;
- •9. Patients with cardiac arrest requiring cardiopulmonary resuscitation within
- •the past 30 days;
- •10. Patient is not expected to survive throughout 28 days of study due to
- •underlying medical condition, such as poorly controlled neoplasm (e.g. Stage
- •III or IV cancer);
- •11. Classified as *Do Not Resuscitate*, or *Do Not Treat*, or the patient*s
- •family is not committed to aggressive management of the patient*s condition. A
- •*no cardiopulmonary resuscitation (CPR)* order is acceptable if the patient
- •and/or the family are still committed to aggressive care short of CPR
- •12. Any concurrent medical condition, which in the opinion of the Investigator,
- •may compromise the safety of the patient or the objectives of the study or the
- •patient will not benefit from treatment such as:
- •* Congestive heart failure (CHF) {New York Heart Association (NYHA) class
- •* Very severe chronic obstructive pulmonary disease (COPD) {GOLD stage IV or
- •use of continuous home oxygen prior to hospital admission (sleep apnoea treated
- •with continuous positive airway pressure or biphasic positive airway pressure
- •oxygen during sleep is acceptable)}
- •* Liver dysfunction {Childs-Pugh class C}
- •* Primary or acquired immunodeficiency or immunosuppression due to treatment
- •with immunosuppressive medications (see Appendix G for list of excluded
- •immunosuppressive medications)
- •* Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes
- •* Neutropenia < 1,000 cells/mm3 not due to the underlying infection
- •* Receiving or about to receive chemotherapy or biologic anti¬cancer treatmen
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