Effects of Oral Iron on Postoperative Fatigue Upon Coronary Artery Bypass Graft Patients

• Status: Terminated
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority
• Collaborators: Capital Health, Canada; Dalhousie University
• Treatments: Iron

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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