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

Phase 2

Completed

• Conditions: Critical illness; Hypophosphatemia; Thiamine deficiency; enteral nutrition; Metabolic and Endocrine - Other metabolic disorders; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12619000121167
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-25
• Study Completion: 2020-12-16
• Last Update Posted: 20 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delta of arterial blood lactate concentration at completion of trial<br><br><br>[Arterial blood lactate will be recorded four times daily (at approximately 6 hour intervals) while the patient is in the ICU and participating in the trial (up to seven days). A sophisticated statistical approach that leverages multiple time points will then be utilised to calculate the change in arterial blood lactate concentrations during trial participation. ]