NCT03941405已完成2 期
Albumin for Management of Hypervolemic Hyponatremia in Patients With Decompensated Cirrhosis. A Proof of Concept Study.
Fundacion Clinic per a la Recerca Biomédica3 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Resolution of hyponatremia
研究概览
简要总结
resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included into the study must meet all the following criteria:
- •This study will include patients with liver cirrhosis and hypervolemic hyponatremia (serum sodium<130 mEq/L) admitted to hospital for any decompensation of the disease. Patients will be enrolled if hyponatremia persists after 3 days of diuretic withdrawal and fluid restriction. Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner. Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
排除标准
- •Patients with Acute kidney injury 1B or higher;
- •Chronic kidney disease grade 3a or higher, defined as glomerular filtration rate <60ml/min for three months and markers of kidney damage (one or more): Albuminuria (Albumin excretion rate > 30 mg/24h; Albumin-to-creatinine ratio > 30 mg/g), Urine sediment abnormalities, Electrolyte and other abnormalities due to tubular disorders, Electrolyte and other abnormalities due to tubular disorders, Abnormalities detected by histology or Structural abnormalities detected by imaging.
- •Previous kidney or liver transplant;
- •Active infection apart from spontaneous bacterial peritonytis based on positive culture (blood, urine, sputum or other samples) or by the following criteria:
- •Urinary infections: signs of systemic inflammation and more than 10 leukocytes per high-power field in urine;
- •Pneumonia: compatible symptoms (cough, purulent sputum, chest pain, shortness of breath) and presence of new infiltrates on chest x-ray;
- •Skin/soft tissue infection: physical exam findings of swelling, erythema, heat and tenderness in the skin;
- •Acute cholangitis: signs of systemic inflammation1, compatible symptoms (right upper quadrant pain and jaundice) and radiological data of biliary obstruction, analytical data of cholestasis;
- •Suspected bacterial infection: signs of systemic inflammation1 but no identifiable origin of this infection (polymorphonuclear cells in ascitic and pleural fluid < 250/mm3, normal urine sediment and chest Xray) After 48 hours of appropriate antibiotic treatment patients can be enrolled.
- •Spontaneous bacterial peritonitis.
- •Hypo or hyperthyroidism not controlled under adequate treatment.
- •Associated heart failure, defined as a New York Heart Association (NYHA) classification III or IV or heart failure with reduced ejection fraction (LVEF<40%). Previously known structural cardiomyopathy including ischemic cardiomyopathy, restrictive cardiomyopathy or valvular cardiomyopathy.
- •Hepatocellular carcinoma beyond Milan criteria.
- •Severe alcoholic hepatitis defined by Maddrey score ≥32 and/or MELD score ≥ 20
- •ACLF with two or more organ failures
- •Treatment with diuretics (furosemide or spironolactone), albumin infusion, somatostatin or terlipresin in the previous 3 days.
- •Symptomatic hyponatremia (manifested by cardio-respiratory distress, abnormal and deep somnolence, seizures or coma) with serum sodium below 120 mEq/L.
- •Previous known hypersensitivity to human albumin
- •Refuse to give informed consent
研究组 & 干预措施
Albumin treatment
Experimental
one dose per day of a 40g albumin g/l gram(s)/litre for 10 days.
干预措施: Albumin treatment (Drug)
结局指标
主要结局
Resolution of hyponatremia
时间窗: for at least 48 consecutive hours during the 10-day treatment
defined as an increase in serum sodium of more than 5 mEq/L with a final value \> 130 mEq/L
次要结局
- partial resolution of hyponatremia(maintained for at least 48 consecutive hours during the 10-day treatment period.)
- Effects of albumin administration on liver phagocytic capacity(levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).)
- Evaluation of systemic hemodynamics(levels at day 0, at day 5 and at day 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days) of the study period.)
- Effects on phagocytic capacity and inflammatory response of peripheral monocytes(levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).)
- Effects of albumin administration of microbiome composition(levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).)
- Effects of albumin administration on development of infections, development of complications of cirrhosis and survival.(levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).)
- Effects on neurocognitive function and quality(levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).)
- Effects on brain water content(levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).)
- Effects of albumin administration on serum albumin levels(levels at day 0, 5, 10, 28 and 90 of study period.)
- evaluate treatment-related serious adverse events(visit day 1,2,3,4,5,6,7,8,9,28 and 90)
- kidney function(levels at day 0, 5 and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).)
- Effects on the inflammatory profile(levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).)
研究者
Anna Cruceta
Project manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (3)
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