EUCTR2014-002440-41-DK进行中（未招募）1 期
Safety and efficacy of iloprost and eptifibatide co-administration compared to standard therapy in patients with septic shock – a randomized, controlled, double-blind investigator-initiated trial - CO-ILEPSS
Rigshospitalet, Capital Region Bloodbank 2034, Section for Transfusion Medicine0 个研究点开始时间: 2014年7月2日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Adult intensive care patients (age =18 years)
- •2. Sepsis, defined as suspected or confirmed site of infection or positive blood culture and =2 of 4 systemic inflammatory response syndrome (SIRS) criteria fulfilled within the last 24h:
- •a) Temperature = 36° C or = 38°C
- •b) Heart rate = 90 beats per minute
- •c) Mechanical ventilation for acute respiratory process or respiratory rate = 20 breaths per min or PaCO2 < 4.2kPa
- •d) WBC = 12,000/mm³ OR = 4,000/mm³ OR > 10% bands
- •3. Septic shock within the last 24h, defined as:
- •a. Hypotension (MAP <70 mmHg, Lactate 4 mmol/L) despite ongoing resuscitation with fluids (crystalloids, colloids, blood products) within the last 24h OR
- •b. =30 ml/kg ideal body weight (IBW) fluid (crystalloids, colloids, blood products) given in the last 24h AND
- •c. Need for vasopressor/inotropic agents (noradrenaline, adrenaline, dopamine) within the last 24h
- •4. Can be randomized into trial and dosed < 24 hours after septic shock diagnosis (the time-point for the septic shock diagnosis corresponds to the time-point where the vasopressor/inotropic therapy (3c) is initiated)
- •5. Consent is obtainable
- •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 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1. Patient is pregnant or breast-feeding
- •2. Patient weights more than 125 kg
- •3. Patients with known allergy towards any of the investigational products or contraindications which
- •should be excluded according to the investigational product specifications
- •4. Patients in whom the clinician finds antithrombotic therapy contraindicated - prophylaxis included
- •5. Patients at increased risk of bleeding:
- •a. Surgery in the previous 48 hours and expected surgery within 48 hours
- •b. Epidural or spinal puncture in the previous 12 hours
- •c. Platelet count less than 10,000/mm3 in the previous 24 hours
- •d. Need of blood products for bleeding in the previous 24 hours (3 or more RBC/24 h)
- •e. Treatment with any antithrombotics within 12 hours (profylaxis excepted)
- •f. Current intracranial bleeding
- •g. Traumatic brain or spinal injury within the last month
- •6. Patients requiring any form of antithrombotics (beyond profylaxis) in therapeutic doses or
- •prothrombotics in any dose, including:
- •a. Unfractionated heparin within 8 hours before the infusion (prophylactic heparin up to 15,000 U/day permitted)
- •b. LMWH within 12 hours before the infusion (prophylactic doses permitted)
- •c. Warfarin within 1 day before the infusion
- •d. Acetylsalicylic acid more than 650 mg/day within 3 days before the study
- •e. Thrombolytic therapy within 3 days before the study (catheter clearance doses permitted)
- •f. GPIIb/IIIa receptor inhibitors within 4 days before the study
- •g. Antithrombin III with dose greater than 10,000 U within 12 hours before the study
- •7. Patients with a do-not-resuscitate order (expected not to survive more than few days because of uncorrectable medical or surgical condition other than sepsis)
- •8. Patient with chronic renal failure requiring dialysis (renal failure without need for dialysis permitted)
- •9. Patients who have undergone transplantation of bone marrow, liver, pancreas, heart, lung, or bowel (kidney transplant permitted)
- •10. Patient with known hypercoagulable condition:
- •a. Activated protein C resistance
- •b. Hereditary protein C, protein S, or antithrombin III deficiency
- •c. Anticardiolipin or antiphospholipid antibody
- •d. Lupus anticoagulant
- •e. Homocysteinemia
- •f. Recent or highly suspected pulmonary embolism or deep venous thrombosis (within 3 months)
- •11. Patients with known congenital hypocoagulable diseases
- •12. Patient with known primary pulmonary hypertension
研究者
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