EAGLE: Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis: A Randomised Multi-centre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU)
研究概览
简要总结
Acute pancreatitis (AP) is a common disorder with rising incidence varying between 35 and 80 per 100,000 in Europe and the USA. About 15% of patients develop necrotizing pancreatitis (NP) with a mortality of up to 42% and frequently prolonged hospitalisation in the survivors. Despite a fulminant pathophysiology comparable to that of sepsis, the management of NP is still re-active, symptomatic and mainly based on paradigms with low grade evidence. In sepsis beneficial effects of early goal-directed fluid resuscitation resulting in reduced mortality have been clearly shown. With regard to these data and several studies of NP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission, early goal-directed fluid resuscitation has the potential of improving outcome also in NP. Therefore, it is the aim of this RCT to demonstrate beneficial effects of early goal-directed resuscitation using an algorithm based on modern haemodynamic parameters such as Intra-thoracic Blood Volume Index (ITBI), Extravascular Lung Water Index (ELWI) and Stroke Volume Variation (SVV) which can be easily and safely obtained due to recent progress in haemodynamic monitoring. The algorithm is aimed at maintaining adequate resuscitation (ITBI, SVV) as well as preventing pulmonary over-hydration (ELWI).The use of a similar algorithm in cardiac surgery patients resulted in a significant reduction in catecholamine use, lactate levels, duration of ventilation and ICU stay.
详细描述
Resuscitation using crystalloids and/or colloids with the following goals:
ITBI: 850 -1000 ml/sqm, if ELWI <=12*ml/kg 750 - 850 ml/sqm, if ELWI >12*ml/kg and/or PaO2:FiO2 <200
*ELWI <=12ml/kg, if MAP>65mmHg without catecholamines <=14ml/kg, if catecholamines required for MAP>65mmHg SVV <10% (only in controlled ventilation and sinus rhythm) MAP >65mmHg (MAP: Mean Arterial Pressure) IAPP >60mmHg (IAPP: Intra-abdominal Perfusion Pressure)
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
- Single (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
- •Diagnosis of pancreatitis:
- •Typical pain
- •Increase in serum lipase or amylase
- •Onset of abdominal pain within <=48h before admission
- •APACHE II >= 8
- •Evidence of >= 1 predictor of severe pancreatitis:
- •Haematocrit >44% (male) or >40% (female), respectively
- •Blood glucose > 125 mg/dl;
- •CRP >= 10 mg/dl;
- •Age > 55 years;
- •Leukocytes >= 16 G/L
- •GOT > 250 U/L;
- •LDH > 350 U/L
- •Calcium < 2,0 mmol/L
- •CK > upper normal range
- •Balthazar-score(CT classification) Grade C-E
- •Any organ failure
排除标准
- •Pre-existing disease with life expectancy < 3 months
结局指标
主要结局
Increase in APACHE II >=4 within 4 days as compared to baseline (admission to ICU)
时间窗: 4 days after admission to the ICU
次要结局
- APACHE-II-Score(4d; 7d; 28d)
- Number of ICU-days(Admission to transfer or death)
- Mortality(ICU-, 28-days- and in hospital mortality)
- Percentage of organ failure within each group(Time of ICU-stay)