Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of malondialdehyde (MDA) in serum from baseline to day 7
研究概览
简要总结
Randomized, double-blind, controlled clinical trial to evaluate the effect of parenteral nutrition (PN) supplemented with lipid emulsions containing 0.1-0.2 g omega 3 polyunsaturated fatty acids (n-3 PUFA)/kg body weight/day for 7 days on malondialdehyde (MDA) levels, a marker of lipoperoxidation of reactive species, compared with a control group (without n-3 PUFA) in patients with intestinal failure (IF).
详细描述
IF is the loss of intestinal function that affects the decrease in the absorption of macronutrients, water, and electrolytes, so it requires intravenous supplementation such as PN and/or intravenous fluids to maintain health and/or growth. IF type II is associated with complex infectious and metabolic complications and patients require PN for weeks or months. Long-term PN use, however, includes the risk of complications, among which a serious one is the intestinal failure-associated liver disease (1). It has been proposed that metabolic endotoxemia (2-3), inflammation (4) and oxidative stress (5) are involved in the development of this intestinal failure-associated liver disease.
Although some studies have reported beneficial effects of n-3 PUFA to prevent and reverse the liver disease associated with IF (6-7), due to its antioxidant (8-10) and anti-inflammatory activity (11-12) and in the modulation of the intestinal microbiota (13), the literature on the use of n-3 PUFA in non-critical patients with IF and PN is limited and the results have not been conclusive.
Therefore, a randomized, double-blind, controlled clinical trial to evaluate the effect of PN supplemented with lipid emulsions containing n-3 PUFA/kg body weight/day for 7 days on oxidative stress (concentrations of MDA), compared with a control group (without n-3 PUFA) will be performed.
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
- Double (Participant, Investigator)
盲法说明
A team researcher will use Stata 12, to perform randomization with a 1:1 allocation using random block sizes of 4. Once the treatment group is determined, the PN will be prescribed accordingly and the preparation will be carried out in the pharmacy and it will have the same appearance in both arms. Patients and researchers who will evaluate the outcomes and perform the statistical analysis will be blinded to the assigned group.
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
- •Patients admitted in the non-critical areas of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) with a nutritional risk between January 2019 and July 2020 will be considered eligible.
- •Patients with recent diagnosis of IF type II (an evolution >28 days) originate from various gastrointestinal or systemic diseases (short bowel, intestinal fistula, intestinal dysmotility, mechanical obstruction, and extensive small bowel mucosal disease).
排除标准
- •Patients with contraindications for PN
- •Patients with known allergies to the components of the PN formula
- •Severe liver or renal insufficiency
- •Uncontrolled diabetes mellitus
- •Certain acute and life-threatening conditions
- •Immunological diseases (such as autoimmune diseases, human immunodeficiency virus infection, cancer, etc.)
- •Those that take immunosuppressant medications
- •Severe hemorrhagic disorders
- •Pregnant or lactating
结局指标
主要结局
Change of malondialdehyde (MDA) in serum from baseline to day 7
时间窗: Change from baseline (day 0) at day 7
Measurement of malondialdehyde (MDA) that is a marker for oxidative stress, determined in serum in ng/dl.
次要结局
- Change of nitrogen ureic in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of urea in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of creatinin in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of sodium in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of potassium in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of phosphorus in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of lipopolysaccharide (LPS) in serum from baseline to day 7.(Change from baseline (day 0) at day 7)
- Change of C-reactive protein (CRP) in serum from baseline to day 7.(Change from baseline (day 0) at day 7)
- Change of glucose in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of glutathione (GSH) in plasma from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of oxidized glutathione (GSSG) in plasma from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of carbonylated protein in serum from baseline to day 7.(Change from day 0 at day 7.)
- Change of urea in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of phosphorus in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of magnesium in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of total bilirubin in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of direct bilirubin in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of indirect bilirubin in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of aspartate aminotransferase in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of C-reactive protein (CRP) in serum from baseline to day 7.(Change from baseline (day 0) at day 7)
- Change of nitrogen ureic in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of creatinin in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of alkaline phosphatase in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Frequency of primary diagnosis at baseline.(At baseline (day 0))
- Frequency of patients with nutritional risk at baseline(At baseline (day 0))
- Determine the type of intestinal failure at baseline.(At baseline (day 0))
- Assessment of nutritional prescription at baseline and at day 7(At baseline (day 0) and at day 7)
- Frequency of the type and characteristics of nutritional support administered(At baseline (day 0) and at day 7)
- Assessment of height at baseline(Baseline (day 0))
- Assessment of weight at baseline and at the end of the follow-up(At baseline (day 0) and at the end of the follow-up (~ at day 30))
- Assessment of body mass index at baseline and at the end of the follow-up(At baseline (day 0) and at the end of the follow-up (~ at day 30))
- Assessment of percentage of lean mass at baseline and at the end of the follow-up(At baseline (day 0) and at the end of the follow-up (~ at day 30))
- Assessment of muscle function at baseline and at the end of the follow-up(At baseline (day 0) and at the end of the follow-up (~ at day 30))
- Length of stay at hospitalization area(From the date of admission to the date of discharge from the hospitalization area (~ at day 30))
- Rate of mortality(At the end of the follow-up (~ at day 30))
- Change in lipidomics in serum from day 0 to day 7(Change from baseline (day 0) to day 7)
- Frequency of intestinal failure-associated liver disease (IFALD)(From baseline (day 0) to the end of the follow-up (~ at day 30))
- Change of oxidized glutathione (GSSG) in plasma from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of carbonylated protein in serum from baseline to day 7.(Change from day 0 at day 7.)
- Change of potassium in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of alanine aminotransferase in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of glutathione (GSH) in plasma from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of GSH/GSSG ratio from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of sodium in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Change of lipopolysaccharide (LPS) in serum from baseline to day 7.(Change from baseline (day 0) at day 7)
- Change of glucose in serum from baseline to day 7(Change from baseline (day 0) at day 7)
- Assessment of resting energy expenditure at baseline(Baseline (day 0))
- Assessment of percentage of fat mass at baseline and at the end of the follow-up(At baseline (day 0) and at the end of the follow-up (~ at day 30))
研究者
Aurora Elizabeth Serralde Zúñiga
Principal Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran