Vitamin B1 (thiamine) administration in enterally-fed critically ill patients with hypophosphatemia: A prospective, randomised clinical trial

Adequate thiamine is an essential co-factor to utilise glucose. There is biological plausibility that phosphate deficiency may identify a cohort at greater risk of thiamine deficiency, and that these deficiencies are synergistic. However, currently, critically ill enterally-fed patients with hypophosphatemia do not receive pharmacological administration of thiamine. Data from the use of thiamine in a wide range of settings suggest that the dose regimen to be evaluated in this trial is tolerable and safe, and this is consistent with the Australian Register of Therapeutic Goods listing of thiamine. However, to the best of our knowledge, there are no studies in the ICU population to evaluate whether pharmacological administration of thiamine to this cohort of patients provides biological, physiological, or even clinical advantages. This multi-site randomised, controlled trial will test whether the intervention (thiamine) administered to patients with hypophosphatemia significantly reduces the primary outcome, blood lactate, which is a robust marker of clinical outcome.