A PHASE III RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED CLINICAL TRIAL 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

Abstract

Fatigue is one of the most prevalent and troublesome symptoms experienced by patients after undergoing coronary artery bypass graft (CABG) surgery. It is often associated with significant morbidity, impairments in mobility, and reduced quality of life (QOL). The etiology of postoperative fatigue (POF) is complicated and multifactorial with several contributing mechanisms. It is not routinely assessed clinically, and treatment is currently based on limited empirical evidence. Effective treatment of fatigue would significantly decrease symptom burden related to CABG surgery. The purpose of this randomized controlled trial (RCT) was to examine whether a single intervention – the administration of a once-daily oral iron tablet – would have an effect on the reported experience of postoperative fatigue among a population of patients undergoing CABG surgery. A sample of 121 patients was recruited, and of those 121 patients, 109 were randomized to a control or an intervention group. Five patients withdrew the day after randomization, and no medication was consumed. One hundred-four patients were entered into the data analysis using the intention to treat approach. Symptom Management Theory (SMT) formed the conceptual and theoretical basis for the study. Results obtained from this study failed to reject the null hypothesis in that there was no statistically significant difference between the primary study outcome of reported fatigue between the control and the intervention groups. Findings from the study do, however, contribute to our knowledge of this poorly understood symptom and provide suggestions for future research. Study results point to the need for refinement of the SMT framework and the need for more structured clinical assessment, focused patient education, and greater attention to the impact of fatigue on postoperative recovery.