Pancreatitis and early omega-3-fatty acid infusion for reduction of organ failure and mortality: a multicenter randomized controlled trial (PLANCTON).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 试验地点
- 16
- 主要终点
- Endpoints will be evaluated after the 180 days study period. The primary endpoint is a composite endpoint of new organ failure (cardiovascular, pulmonary or renal) and mortality. Definitions New onset organ failure is defined as organ failure that was not present at randomization. Organ failure is addressed according to the modified Marshall score
研究概览
简要总结
Overall study hypothesis Based on the literature, there seems to be a relation in AP between (hyper)inflammation, SIRS, new onset of organ failure and mortality. Omega3 fatty acids seem to have clinical beneficial effects through immunomodulation, supported by the decreased inflammatory biomarkers in patients with AP. Therefore, the following hypothesis was formulated: Early intravenous administration of Omega3 fatty acids reduces the composite endpoint of new onset organ failure and/or mortality in patients with predicted SAP.
Overall study objective To investigate whether early intravenous administration of Omega3 fatty acids compared to standard medical care has beneficial effects and reduces the combined endpoint of new onset organ failure and/or mortality in patients with predicted SAP.
Objectives randomized controlled trial Secondary aims in this study are to investigate the effect of Omega3 fatty acids supplementation on i.e. the separate endpoints of the combined endpoint, (serious) adverse events, hospital and ICU stay, need for interventions, hospital costs, and quality of life.
研究设计
- 分配方式
- Randomized
- 主要目的
- Plancton Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Predicted severe AP (The diagnosis of acute pancreatitis and one or more of the following, within 24hrs:
- •APACHE-II score above 7
- •Modified Glasgow score above 2
- •CRP-level above 150 mg per L)
- •minimum of 18 years old
- •First episode of AP
- •less than 24 hours after diagnosis of AP
- •less than 72 hours after onset of symptoms of AP
- •Able to read and or understand the study procedures
- •Able to give informed consent (or their legal representatives)
- •Definitions: Acute pancreatitis: at least 2 of these 3 features11:
- •Upper abdominal pain
- •Serum lipase and or amylase levels 3 times the upper level of normal
- •Characteristic findings of AP on contrast enhanced computed tomography scan (CECT). Usually, no CECT imaging is needed as the diagnosis can be made with the findings under 1 and 2
排除标准
- •Intake of any omega3 fatty acids-, krill and or algae supplements in the week prior to complaints
- •Acute thrombo-embolic disease
- •Pregnancy or lactation
- •Recent (less than 6 months) myocardial infarction or stroke
- •Known coagulations disorders (e.g. Factor V Leiden, thrombocytopenia, etc.)
- •Pancreatitis due to a (suspected) periampullary or ampullary or bile duct malignancy
- •Other known or suspected malignancy that may interfere with the outcome(s) and or execution of the PLANCTON trial
- •Post ERCP-pancreatitis due to a (suspected) malignancy
- •Patient is classified as moribund or expected to die within 24hours The intervention will not be able to affect this patient and is therefore useless to expose these patients.
- •Participation in another intervention study for AP
- •Organ failure on admission (Modified Marshall score more than 2)
- •Recurrent pancreatitis
- •Chronic pancreatitis (Defined by the MANNHEIM criteria)
- •Known allergy to fish oil, seafood, soja or egg products
- •History or existing hyperlipidemia (laboratory proven triglycerides more than 10.0 mmol per litre)
- •History of (severe) liver failure. (Impaired lipid metabolism may lead to accumulation of fatty acids in the blood, increasing risk of adverse events) Based on coagulation Factor V level or INR more than 3 (without anti-coagulation by vitamine K)
- •Ketoacidosis
结局指标
主要结局
Endpoints will be evaluated after the 180 days study period. The primary endpoint is a composite endpoint of new organ failure (cardiovascular, pulmonary or renal) and mortality. Definitions New onset organ failure is defined as organ failure that was not present at randomization. Organ failure is addressed according to the modified Marshall score
Endpoints will be evaluated after the 180 days study period. The primary endpoint is a composite endpoint of new organ failure (cardiovascular, pulmonary or renal) and mortality. Definitions New onset organ failure is defined as organ failure that was not present at randomization. Organ failure is addressed according to the modified Marshall score
次要结局
- New onset organ failure (during follow-up)
- Individual components of the primary outcome
- Mortality (during follow-up): 14-day mortality or 28-day mortality or In hospital mortality
- Infectious complications (i.e. pneumonia, urinary tract, wound infections or infected (peri-) pancreatic necrosis)
- The need (and number of) for surgical, endoscopical or radiologic interventions
- CRP level on day 0, 1, 2, 3, 5 and 7
- Total length of hospital stay (days)
- Total length of ICU stay (days)
研究者
Anne Nagelhout
Scientific
Stichting Radboud University Medical Center