A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Enteral Iron Supplementation on Anemia and Risk of Infection in Critical Illness
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Serum Ferritin Concentration
研究概览
简要总结
The purpose of this study is to investigate the efficacy of enteral iron supplementation for improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in patients who are hospitalized in the intensive care unit. This study will also address any relationship between enteral iron supplementation and risk of infection.
详细描述
Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoiesis into storage within the reticuloendothelial system as ferritin. Also the majority of critically ill patients are hypoferremia, the efficacy of iron supplementation remains unknown. Furthermore, several retrospective studies have found an association between iron overload and infection. However, the relative risk/benefit profile of enteral iron supplementation with respect to infection has not been studied. The purpose of this study is to evaluate the efficacy of enteral iron supplementation in critically ill patients. The hypothesis is that enteral iron supplementation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18 years
- •Anemia (Hemoglobin < 13.0 g/dL)
- •≤ 72 hours from hospital admission
- •Current tolerance of enteral medications
- •Expected ICU LOS > 5 days
排除标准
- •Active bleeding
- •Chronic inflammatory disease
- •End-stage renal disease
- •Hematologic disorders
- •Macrocytic anemia
- •Current use of erythropoietin
- •Pregnancy
- •Prohibition of RBC transfusions
- •Moribund state in which death is imminent
- •Enrollment in another clinical trial
研究组 & 干预措施
Iron Group
Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
干预措施: Ferrous Sulfate (Drug)
Placebo Group
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Serum Ferritin Concentration
时间窗: Day 7, Day 14, Day 21, Day 28
Hematocrit
时间窗: Day 7, Day 14, Day 21, Day 28
Serum Iron Concentration
时间窗: Day 7, Day 14, Day 21, Day 28
Erythrocyte Zinc Protoporphyrin Concentration
时间窗: Day 7, Day 14, Day 21, Day 28
次要结局
- Average Length of Stay in the Hospital(Throughout hospital stay up to 6 weeks)
- Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital(Throughout hospital stay up to 6 weeks)
- Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission(Throughout hospital stay up to 6 weeks)
- Average Number of Days That Subjects Were Taking Antibiotics(Throughout hospital stay up to 6 weeks)
- Instance of Drug-related Constipation Throughout Hospital Admission(Throughout hospital stay up to 6 weeks)
- Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital(Throughout hospital stay up to 6 weeks)