EUCTR2005-004636-52-GB进行中（未招募）不适用
Randomised Double-Blind Placebo Controlled Trial of 40mg/day of Atorvastatin on Reduction in Severity of Sepsis in Ward Patients - Clinical trial of Atorvastatin on Reduction in Severity of Sepsis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 414
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
- •A. Age > 18 years;
- •B. One of following documented source of infection:
- •(1). Pneumonia is defined as clinical signs:
- •cough or new sputum production or dyspnoea or chest pain or rales
- •and an infiltrate on CXR;
- •(2). Urinary tract infection is defined as > 1 of following criteria:
- •urgency or frequency, or dysuria, or suprapubic tenderness
- •and > 1 of the following:
- •a. positive dipstick for leukocyte esterase and/or nitrate;
- •b. pyuria (urine specimen with > 10 white blood cells /mm
- •or > 3 white blood cells per field of unspun urine;
- •c. organisms seen on Gram’s stain of unspun urine.
- •(3). Cellulitis or bone/joint infection is defined as erythema, pain, swelling, warmth of the affected skin or joints and limited movement.
- •(4). Abdominal infection is defined as > 1 of following criteria:
- •a. abdominal distension and tenderness, or local discomfort or peritonism;
- •b. abdominal mass, e.g. gall bladder, pseudocyst, abscess;
- •c. failure to tolerate enteral feed or nasogastric aspirates > 200ml/4hrly;
- •d. diarrhoea;
- •e. laparotomy for perforation or obstruction;
- •f. pancreatitis, or cholecyctitis, or gynaecological infection, or pyelonephritis;
- •g. abdominal collection shown on CT, ultrasound or abdominal X-ray.
- •(5). Meningitis is defined as > 1 of following criteria:
- •a. headache with stiff neck;
- •b. focal neurological signs;
- •c. LP positive;
- •d. CT: raised ICP is suspected.
- •(6). Endocarditis: fever and changing murmur are signs of suspected endocarditis.
- •(7). Catheter or device infection: localised cellulitis.
- •C. > 2 of the following signs of systemic inflammation in response to infection:
- •(1). Core temperature: > 38.3C or < 36C;
- •(2). Heart rate: > 90 bpm, except in patients with a known medical condition to increase the heart rate or those receiving treatment that would prevent tachycardia;
- •(3). Systolic BP < 90 mmHg, or MAP < 70 mmHg;
- •(4). Decreased capillary refill or mottling;
- •(5). Urine output < 0.5 ml/kg/h for more than 2 hrs;
- •(6). Respiratory rate: > 20 breaths /min
- •or a PaCO2 < 4.3 or PaO2/FiO2 < 40, but > 26.8 kPa;
- •(7). Ileus (absent bowel sounds);
- •(8). Altered mental status;
- •(9). Significant oedema or positive fluid balance (> 20 ml/kg over 24 hrs);
- •(10). White cell count: > 12 000/mm or < 4000/mm
- •or a differential count showing >10% immature neutrophils;
- •(11). C-reactive protein > 2 SD above the normal value;
- •(12). Plasma glucose > 7.7 mmol/l in the absence of diabetes;
- •(13). Platelets count <100,000, but > 49, 000/µl, or INR > 1.5 or APTT > 60s;
- •(14). Plasma lactate > 2 mmol/l;
- •(15). Bilirubin > 40, but < 101 µmol/l;
- •(16). Creatinine > 120, but < 177 µmol/l.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •Signs of severe sepsis: septic patients with any one of the following signs:
- •(1). PaO2/FiO2 < 26.7 kPa;
- •(2). Noradrenaline/adrenaline > 0.1 µg/kg/min;
- •(3). Creatinine > 330 µmol/L;
- •(4). Platelets <50 x 103/ mL;
- •(5). Bilirubin > 102 µmol/L;
- •(6). Glasgow Coma Score < 9.
- •Known active liver disease, alcohol abuse
- •or persistently abnormal liver function tests:
- •alanine aminotransferase, or creatine kinase > 3 times the upper limit
- •of laboratory normal ranges;
- •Pregnancy, breast-feeding or women of childbearing potential not using adequate contraception;
- •Previous adverse reaction to statins;
- •Concomitant use of fibrates or other lipid-lowering therapy;
- •Administration of atorvastatin was ceased <2 weeks prior to the trial
- •(wash-out period in healthy volunteers: 7 days);
- •Concomitant use of erythromycin, telithromycin, clarithromycin itraconazole, imidazoles, triazoles, ciclosprin or grapefruit juice21;
- •Participation in another clinical trial;
- •Patients with terminal cancer;
- •Fail to obtain written consent.
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