EUCTR2022-000474-26-NL进行中（未招募）1 期
Pancreatitis and early omega-3-fatty acid infusion for reduction of organ failure and mortality: a multicenter randomized controlled trial (PLANCTON) - PLANCTO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 入组人数
- 212
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
- •Predicted severe acute pancreatitis
- •=18 years old
- •First episode of acute pancreatitis
- •<24 hours after diagnosis of acute pancreatitis
- •<72 hours after onset of symptoms of acute pancreatitis
- •Able to read and/or understand the study procedures
- •Able to give informed consent (or their legal representatives)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 212
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 212
排除标准
- •Intake of omega-3 fatty acids
- •Participation in another intervention study for acute pancreatitis
- •Organ failure on admission (Modified Marshall score >2)
- •Recurrent pancreatitis
- •Chronic pancreatitis
- •oDefined by the MANNHEIM criteria
- •Known allergy to fish oil, seafood, soja or egg products
- •History or existing hyperlipidemia (laboratory proven triglycerides > 10.0 mmol/l)
- •History of (severe) liver failure
- •oImpaired lipid metabolism may lead to accumulation of fatty acids in the blood, increasing risk of adverse events.
- •oBased on coagulation Factor V level or INR > 3
- •(without anti-coagulation by vitamine K)
- •Ketoacidosis
- •Acute thrombo-embolic disease
- •Pregnancy or lactation
- •Recent (< 6 months) myocardial infarction or stroke
- •Known coagulations disorders (e.g. Factor V Leiden, thrombocytopenia, etc.)
- •Patient is classified as moribund or expected to die within 24hours
- •oThe intervention will not be able to affect this patient and is therefore useless to expose these patients.
研究者
相似试验
招募中
不适用
Effect of omega-3 fatty acids administration in adjuvant chemotherapy for biliary tract cancer: an open-label, single-arm study.Biliary tract chancerJPRN-UMIN000031247Kobe University Graduate School of Medicine Department of Surgery Division of Hepato-Biliary-Pancreatic Surgery55
招募中
2 期
Effect of Omega-3 Supplementation on Dry EyeDry eye syndromeIRCT20240308061214N1Islamic Azad University120
进行中（未招募）
不适用
Add-on Therapie mit Omega-3 Fettsäuren bei Jugendlichen mit hohem Risikofür Schizophrenie und andere psychotische Störungen: eine Multizentren-ReplikationsstudieOmega-3 Fatty Acids for Symptomatic Patients at Ultra-High Risk for Early Progression to Schizophrenia and Other Psychotic Disorders: A Multicentre ReplicationStudy - Omega-3 fatty acids for indicated prevention of psychotic disordersIn view of recent data and after a careful review of potentially neuroprotective treatment options in early psychotic illness, we have decided to replicate the findings of a randomized controlled trial of Amminger et al. (ClinicalTrials.gov, number NCT00396643) studying the efficacy of omega-3 fatty acids (EPA/DHA) in young patients at ultra-high-risk for psychosis preventing the onset of schizophrenia or other psychotic disorders.EUCTR2008-005004-13-ATOrygen Research Centre320
已完成
不适用
Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Diseases DiseaseParkinson's DiseaseJPRN-UMIN000008057St. Mariannna University School of Medicine25
已完成
2 期
The effect of omega3 fatty acid capsules on primi gravida during pregnancy depressiodepression.episode-depressive-mildIRCT2012121011717N1Vice chancellor for research, Shiraz University of Medical Sciences80