Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
研究概览
简要总结
Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis
排除标准
- •chronic pancreatitis
- •liver cirrhosis (Child-Pugh B and C)
- •chronic hearth failure (NYHA>II)
- •acute coronary syndrome
- •cardiovascular intervention within 60 days before randomization
- •chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease
- •chronic kidney disease (eGFR <30 ml/min/1.73 m2)
- •concomitant biliary infection (cholecystitis, cholangitis)
- •severe autoimmune disease
- •chronic active infection (TBC, AIDS)
- •metastatic malignant disease
- •primary pancreatic neoplasm
- •patients transferred from other hospitals
- •pregnancy and ongoing breastfeeding
- •not willing to participate
研究组 & 干预措施
Balanced crystalloid solution
Balanced crystalloid solution - Plasmalyte.
干预措施: Balanced crystalloid solution (Drug)
Normal saline
0.9% sodium chloride solution.
干预措施: Normal saline (Drug)
结局指标
主要结局
Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
时间窗: 30 days
Body temperature less than 36 °C (96.8 °F) or greater than 38 °C (100.4 °F); heart rate greater than 90 beats per minute; tachypnea (high respiratory rate), with greater than 20 breaths per minute or, an arterial partial pressure of carbon dioxide less than 4.3 kilopascals (32 mmHg); white blood cell count less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L) or the presence of greater than 10% immature neutrophils.
次要结局
- Mortality(30 days)
- Number of participants with organ failure (transitory and persistent)(30 days)
- Number of participants with local complications(30 days)
- Number od participants with systemic complications(30 days)
- Number of participants with infected pancreatic necrosis(30 days)
- Number of participants needing endoscopic / percutaneous / surgical interventions(30 days)
- Length of hospital stay(30 days)
研究者
Goran Poropat
Asst. Prof.
University Hospital Rijeka