Does Intraoperative Intravenous Iron Enhance Postoperative Oxygenation Profile and the Recovery of Hemoglobin in Total Knee and Hip Arthroplasty Surgery?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The changes of Hemoglobin between preoperative and postoperative day 30
研究概览
简要总结
The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2 ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb total knee arthroplasty surgery.
详细描述
Participation and recruitment: Patients undergoing elective total knee arthroplasty due to osteoarthritis will be interviewed for participation and recruited after providing written informed consent.
Randomization and group allocation:
All recruited patients will be given patient identification number (PIN) for the present study of 01-77 according to their order of interview and recruitment.
Investigators will prepare 33 yellow and 34 green cards, which will be inserted in 77 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 77 (Envelop number).
After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery
- •Patients provided a written informed consent.
- •Patients with s-ferritin < 300 mg/dl (male) or 200 mg/dl (female)
- •Patients with preoperative serum hemoglobin concentration >10 g/dL
- •Patients with PaO2/FiO2 ratio >150
排除标准
- •Patients with history of anaphylaxis, iron overload, active infection.
- •Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
研究组 & 干预措施
Experimental group
ferric carboxymaltose 1000 mg
干预措施: ferric carboxymaltose 1000 mg (Drug)
Control group
placebo
干预措施: placebo (Drug)
结局指标
主要结局
The changes of Hemoglobin between preoperative and postoperative day 30
时间窗: postoperative 30 days
intergroup-difference in hemoglobin change
the changes of arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)
时间窗: postoperative 5 days
intergroup-difference in PaO2/FiO2 ratio
次要结局
- serum hemoglobin concentration(postoperative 30 days)
- arterial oxygen tension/inspired oxygen (PaO2/FiO2 ratio)(postoperative 5 days)
研究者
Tae-Yop Kim, MD PhD
Professor
Konkuk University Medical Center