High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in Il-6 concentration
研究概览
简要总结
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed.
详细描述
All patients depended on parenteral nutrition (PN) are prone to inflammation. This condition may aggravate already existing proinflammatory status and can become a critical factor for developing liver dysfunction (LD). Intravenous fish oil may attenuate the inflammatory status, , however, data on its use in adults is scarce. The aim of the study was to investigate the impact of the addition of pure fish oil intravenous lipid emulsion (ILE) as part of short- and long term PN in patients either at risk or with already existing inflammation.
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed. Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d. Diagnoses were chronic intestinal failure (CIF, n=20), Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19). The observation period was 12 months for CIF and 21days for UC and CD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •≥ 18 years of age,
- •metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month)
- •ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN.
排除标准
- •patients with a history of cancer and anti-cancer treatment within the last 5 years, severe hyperlipidemia, severe coagulopathy, severe renal insufficiency, acute thromboembolic events, positive test for HIV, Hepatitis B or C (from medical history), known or suspected drug or alcohol abuse, participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial, for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.
研究组 & 干预措施
Inflammatory bowel disease
Patients with either Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19).
干预措施: Omegaven (Drug)
Chronic intestinal failure
Patients with intestinal failure (CIF, n=20)
干预措施: Omegaven (Drug)
结局指标
主要结局
Change in Il-6 concentration
时间窗: 4 weeks
Serum concentration of Il-6 (pg/mL)
Change in bilirubin concentration
时间窗: 4 weeks
Serum concentration of bilirubin (umol/L)
Change in SGPT concentration
时间窗: 4 weeks
Serum concentration of SGPT(U/l)
Change in procalcytonin concentration
时间窗: 4 weeks
Serum concentration of procalcytonin (ng/mL)
Change in C-reactive protein concentration
时间窗: 4 weeks
Serum concentration of CRP (mg/l)
Change in hsCRP concentration
时间窗: 4 weeks
Serum concentration of hsCRP (pg/mL)
Change in interleukin-10 concentration
时间窗: 4 weeks
Serum concentration of IL-10 (pg/mL)
Change in SGOT concentration
时间窗: 4 weeks
Serum concentration of SGOT (U/l)
Change in alkaline phosphatase concentration
时间窗: 4 weeks
Serum concentration of alkaline phosphatase (U/l)
次要结局
未报告次要终点
研究者
Stanislaw Klek
Head of the Unit
Stanley Dudrick's Memorial Hospital