NCT01376817Unknown4 期
Comparative Study About the Impact of Two Oil Emulsions, One of Them Formulated With MCT, LCT, Olive Oil and Omega 3 Fatty Acids Versus Another One Formulated With MCT and LCT, Administered Intravenously on Severe Acute Pancreatitis Clinical Evolution
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Inflammatory markers
研究概览
简要总结
The purpose of this study is to comparatively assess the potential antiinflammatory effects of intravenous lipid emulsions rich in omega 3 polyunsaturated fatty acids and olive oil versus intravenous lipid emulsions made exclusively with MCT and LCT on the evolution of patients with severe acute pancreatitis during the period in needing artificial nutrition support with total parenteral nutrition so unique.
详细描述
Information recorded in other data elements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 acute pancreatitis: characteristic abdominal pain, serum amylase and / or lipase >= 3 times the upper limit of normal range, characteristic CT-scan
- •Criteria of severity of acute pancreatitis diagnosed at <= 72 hours following admission: severity Index of Balthazar's CT-scan (with contrast) >= grade D, APACHE-II >= 8, C-reactive protein >= 150 mg/L
- •Inability to initiate feeding (oral or with nutritional supplements) and / or enteral nutrition during the 5 days after the diagnosis and prediction of the indication of nil-by-mouth >= 5 days
- •<= 3 mmol/L of triglycerides in the blood
- •Men and women aged >= 18 years old
- •Acceptance of informed consent
排除标准
- •Known hipersensitivity to the fish, egg or soy proteins
- •Lipid etiology
- •> 3 mmol/L of triglycerides in the blood
- •Severe hepatic impairment
- •Severe renal insufficiency without dialysis or haemofiltration
- •Serious disturbances of blood clotting
- •Acute shock
- •Infusion therapy general contraindications
- •Clinical conditions of instability that must not be taken with parenteral nutrition
- •Have other acute or chronic inflammatory diseases
- •Status of severe immunosuppression: cytotoxic treatment in 15 days prior to inclusion and / or a disease that causes white blood cells levels <5000/mm3
- •Treatment with steroids > 0.25 mg/kg/day of prednisone or equivalent doses of corticosteroids: as pre-treatment and / or during admission
研究组 & 干预措施
Omega 3
Experimental
干预措施: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids (Drug)
MCT / LCT
Active Comparator
干预措施: Fat emulsion with MCT and LCT (Drug)
结局指标
主要结局
Inflammatory markers
时间窗: Day 10
LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10
次要结局
- Evolution of the degree of severity of acute severe pancreatitis(During the first 72 hours after admission)
- Complications of acute severe pancreatitis(Day 10.)
研究者
研究点 (1)
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