Phase III Randomized Double Blind Placebo-Controlled Study To Assess The Effects Of FeraMax When Administered Orally Once A Day On Postoperative Fatigue Levels In Patients Following Elective Coronary Artery Bypass Graft Surgery (CABG)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Fatigue Level
研究概览
简要总结
The purpose of this research study is to examine how an oral iron supplement (Feramax®) influences fatigue during early postoperative recovery (at three months) among CABG patients and, the effects on recovery outcomes (e.g. quality of life, functional capacity, anemia, and medication adherence).
It is hypothesized that CABG surgery patients receiving oral iron (Feramax®) 150mg orally (once a day therapy) will have a 15% reduction in POF (measured by the Identity Consequence Fatigue Scale (ICFS)), compared to patients receiving a placebo.
详细描述
Postoperative fatigue (POF) is one of the main complaints in approximately 39-80% of CABG surgery patients. POF can have a significant impact on an individual's quality of life (QoL) and recovery. The objectives are to examine how an oral iron (Feramax®) influences fatigue during early postoperative recovery (at three months) among CABG patients and determine the effects on recovery outcomes (e.g. QoL, functional capacity, anemia, and medication adherence). To achieve these objectives the research will aim to answer the following questions:
- Is oral iron effective in reducing POF measured by the Identity Consequence Fatigue Scale (ICFS) over 12 weeks?
- If oral iron is effective, how effective was it on improving fatigue, functional capacity, QoL, and anemia?
- To what degree do patients taking oral iron adhere to the prescription? A prospective, randomized, double-blind placebo-controlled, single-center study was chosen for this study. Three hundred participants who are scheduled for an isolated CABG surgery will be recruited from the QEII Health Sciences Centre (QEIIHSC), Halifax, Nova Scotia. All study participants will be followed for three months following hospital discharge.
Data will be collected at five time points:
Time point 1 Baseline -Patients are screened in the preadmission clinic or nursing unit and recruited for the study. During this visit, the patient will be assessed for eligibility, demographic data and blood work collected and three questionnaires and six minute walk test completed by participants.
Time point 2 Discharge/Randomization-Patients will be randomized to either FeraMAX® or placebo at hospital discharge. The treatment will be taken once daily for 84 days starting Day 1 (day after discharge from hospital). The questionnaires, six minute walk test and blood work will be repeated.
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
- Triple (Participant, Investigator, 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
- •Non-Urgent, first time, coronary artery bypass grafting.
- •American Society of Anesthesia (ASA) physical status II-IV
- •Aged 19 years and older
- •Able to make informed consent by understanding the nature of the participation
- •Able to read and write English to the degree necessary to participate in interviews and questionnaires
排除标准
- •Had prior median sternotomy surgery
- •A Hemoglobin greater than or equal 120g/L at discharge
- •Previous history of noncompliance with oral medications
- •Received erythropoiesis-stimulating agents (e.g. epoetin alfa and darbepoetin alfa) postoperatively to discharge
- •Allergy to iron History of hematological disorders that are deemed clinically significant as per the investigator's clinical judgment
- •Received Clopidogrel within two days prior to surgery, greater than 81mg of Acetylsalicylic acid 24 hours prior to surgery, or have received "new oral anticoagulants" (e.g. Apixaban, Rivaroxaban, and Dabigatran) within the recommended preoperative exclusion period
- •History of iron metabolism disorders e.g. known iron overload, hemochromatosis, porphyria
- •Chronic fatigue syndrome (a condition that is distinguished from other types of fatigue by fatigue lasting more than six months and has at least four other symptoms (e.g. sleep disturbances, headaches, joint pain, and concentration difficulties) that could contribute to increased fatigue (Afari & Buchwald, 2003)).
- •A serum transferrin saturation of more than 50% at discharge
- •History of Fibromyalgia
- •Current diagnosis of depressive disorder
- •History of Hypothyroidism includes uncontrolled thyroid disease (abnormal Thyroid Stimulating Hormone (TSH) or Thyroxine (T4) at screening visit) as per the Investigator's clinical judgment
- •Patient taking iron supplementation ≤ 60 days before surgery and in the postoperative period
- •Any other unstable conditions as per the Investigator's clinical judgment
- •Contraindications to the six-minute walk test
- •Physical disability preventing safe performance
- •Resting heart rate > 120 beats/min 10 min after rest (relative contraindications)
- •Systolic blood pressure >180mm ± Diastolic blood pressure > 100mm Hg (relative contraindications)
- •Resting Sp02 <85% on room air or on a prescribed level of supplemental oxygen
研究组 & 干预措施
FeraMax
FeraMax Polysaccharide iron complex oral iron supplement 150mg one capsule orally daily
干预措施: Polysaccharide iron complex (Drug)
Placebo
one capsule orally daily
干预措施: Placebo (Drug)
结局指标
主要结局
Fatigue Level
时间窗: 12 weeks after surgery
Identity Consequence Fatigue scale
次要结局
- Anemia(12 week after surgery)
- Functional Capacity(12 weeks after surgery)
- Health Related Quality of Life(12 weeks after discharge from hospital)
- Medication Adherence(12 weeks after surgery)
研究者
Blaine Kent MD
Anethesiology
Nova Scotia Health Authority