A Phase-II, double-blind, randomized, placebo-controlled study on the safety and early efficacy of Alkaline Phosphatase in sepsis patients with Renal Failure. - niet van toepassing

AM-Pharma B.V.0 个研究点目标入组 39 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 39

研究概览入排标准研究者记录与标识符相似试验

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

•Patients >=18 years and <=80 years.
•Proven or suspected infection.
•Two out of four SIRS criteria of systemic inflammation, as follows:
•Core temperature >=38°Celsius or <=36° Celsius.
•Heart rate >=90 beats/min (unless the patient has a medical condition known to increase heart rate or is receiving treatment that would prevent tachycardia).
•Respiratory rate >=20 breaths/min, a PaCO2 <=32mmHg or the use of mechanical ventilation for an acute respiratory process.
•White-cell count >=12,000/mm3 or <=4,000/mm3 or a differential count showing >10 percent immature neutrophils.
•Acute renal failure, defined as - a rise in serum creatinine level to >= 150µmol/l within the previous 48 hours, in the absence of primary underlying renal disease OR - minimally a stage 1 Kidney injury according to AKIN creatinine criteria: Increase in serum creatinine >= 26.2 umol/l (0.3mg/dl) or increase to >= 150% (>=1.5 fold) from baseline in the previous 48 hours (in the abscence of primary underlying renal disease and where baseline creatinine is less than 150umol/l) OR -minimally a stage 1 Kidney Injury according to AKIN Urine utput criteria: oliguria, defined as urine output <=0.5mL/kg/hr for >=6 hours and following adequate fluid resuscitation when applicable, in the absence of primary underlying renal disease and where baseline creatinine is less than 150 umol/l,
•patient already on renal replacement therapy (RRT, dialysis) due to renal impairment secondary to sepsis.
•Written informed consent obtained prior to any study intervention.
•In addition to the above, the following common conditions may be present (not compulsory for patient qualification for enrolment):
•Acute onset of end-organ dysfunction (other than renal failure) in the preceding 12 hours unrelated to the primary septic focus and not explained by any underlying chronic disease such as:
•Sustained hypotension or organ dysfunction that is the result of sepsis and not the patient*s underlying disease or treatment, as evidenced by one or more of the following criteria for less than 12 hours:
•Systolic blood pressure <=90mmHg or mean arterial pressure <=70mmHg for at least one hour (by two or more measurements) despite adequate fluid intake, OR
•requirement for vasopressor support to maintain MAP
•Acute alteration in mental state not due to sedation or of primary underlying disease of the central nervous system.
•Acute hypoxemic respiratory failure, defined by a PaO2(/FiO2 ratio <40kPa (300mmHg) in the absence of primary underlying pulmonary disease.
•Disseminated intravascular coagulopathy defined by either:
•Platelet count <=100*109/L
•Coagulation abnormality (PT=1.2 times control or APTT=1.2 times control)
•Metabolic acidosis defined as pH*7.30 or base excess *-5mmol/L in association with a plasma lactate *3.0mmol/L
•Acute hepatic failure, defined by at least 2 of the following criteria, in absence of primary underlying hepatic disease:
•serum bilirubin concentration >43µmol/L
•serum ALAT/ASAT concentration greater than twice the upper limit of normal range
•prothrombin time >1.5 times the control value OR an International Normalized Ratio >1.5 in the absence

排除标准

•Pregnant women or nursing mothers and fecund females who are not on effective contraception (chemical: pill; or mechanical: IUD)
•Known HIV (sero-positive) patients
•Patients already on dialysis (RRT) at entry
•Patients receiving immunosuppressant therapy or on chronic high doses of steroids equivalent to prednisone 1mg/Kg/day
•Patients expected to have rapidly fatal disease within 24 hours
•Known confirmed gram-positive sepsis
•Known confirmed fungal sepsis
•Acute pancreatitis with no established source of infection
•Patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm or other diseases
•Participation in another investigational study within 90 days prior to start of the study which might interfere with this study
•Any previous administration of active study medication.
•Known allergy for dairy (bovine) products including cow milk.
•Sepsis without renal failure as defined in the Entry Criteria.
•History of chronic renal failure or history of persistent creatinine level equal or greater than 150umol/L prior to entry for reasons other than the current sepsis condition.

研究者

发起方

AM-Pharma B.V.

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