None listed
Conditions
Brief summary
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.
Interventions
Intervention: Thiamine (200mg every 12 hours)
Thiamine (100mg/mL) will be administered intravenously as 200mg in 100mL sodium chloride 0.9% over 30 minutes. Infusions will occur twice daily while participants remain in the ICU, for a maximum of seven days, and only in participants randomised to receive the intervention. Fidelity to the intervention will be monitored regularly by research staff through review of nurses notes and medication charts.
Alternative name: Vitamin B1
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Critically ill patient admitted to the ICU • Receiving enteral nutrition (EN) for <= 72 hours in this ICU admission • A serum phosphate <= 0.65mmol./L in the last 24 hours while receiving EN
Exclusion criteria
• Patients who have received >= 100mg of intravenous (IV) thiamine in the previous 48 hours • Patient is anticipated to be discharged from the ICU today or tomorrow • Treating clinician believes that either treatment (to receive or not to receive IV thiamine) is in the best interest of the patient • Aged < 18 years • Patients with a known or suspected hypersensitivity to thiamine • Patients receiving palliative care • Pregnancy • Patients admitted for consideration of organ donation • Patients previously enrolled in this trial • Patients with a known latex allergy • Patients with documented or suspected acute beri-beri disease • Patients with documented or suspected acute Wernicke's encephalopathy
Outcome results
None listed