RecruitingPhase 2Phase 3ACTRN12623000589684

How much thiamine is enough in malnourished patients receiving total parenteral nutrition?

Thiamine levels and duration of replacement in patients receiving total parenteral nutrition (TPN) with moderate to severe risk of refeeding - a prospective randomised controlled trial


Sponsor

Sir Charles Gairdner Hospital

Enrollment

65 participants

Start Date

Jun 15, 2023

Study Type

Interventional

Conditions

Summary

Thiamine deficiency manifests as two conditions: cardiac (wet) beriberi, or Wernicke’s encephalopathy. Furthermore, it can potentiate lactic acidosis through failure of pyruvate to enter the Kreb’s cycle. Patients who are malnourished are at risk of thiamine deficiency, and traditionally, replacement is given for patients at risk (patients on TPN without micronutrients, those with history of alcohol abuse, starvation states). Thiamine levels are not routinely checked in usual practice, but instead, supplementation is provided based on risk. The current guidelines give different recommendations (excluding for treatment of beriberi/Wernicke’s, in which the dose is 200-500mg intravenously three times a day for 5-7 days followed by 100mg for 1-2 weeks) 1. For those at high risk of thiamine deficiency, therapeutic guidelines suggests giving 300mg intravenously for 3 days and then 100mg daily for 1-2 weeks 2. In re-feeding syndrome 100mg intravenously for 7-10 days Clinical Question Is 3 days of intravenous thiamine replacement in patients receiving TPN AND at risk of refeeding syndrome, sufficient to restore and maintain thiamine levels when measured at day 7? Hypothesis In patients at risk of refeeding syndrome, thiamine levels are sufficiently restored with 3 days, as opposed to 7 days, of supplementation. Methodology Patients randomized to receive 3 days of intravenous thiamine or 7 days of intravenous thiamine. Standard dose will be given, 250mg b dose forte intravenous. Thiamine levels will be measured at day 0, 3 and 7 to ensure adequate blood levels are reached.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Thiamine (Vitamin B1) is an essential nutrient, and people who are malnourished — especially those being fed intravenously in hospital — can develop dangerous thiamine deficiency. Without enough thiamine, the heart and brain can be affected, causing serious complications. Current treatment guidelines recommend thiamine supplementation for at-risk patients, but the optimal duration of intravenous thiamine is not well-defined. This study compares giving intravenous thiamine for three days versus seven days in patients receiving total parenteral nutrition (IV feeding) who are at risk of refeeding syndrome. Blood tests will be taken on days 0, 3, and 7 to check whether three days of supplementation is enough to restore and maintain safe thiamine levels. You may be eligible if you are an adult receiving total parenteral nutrition (IV nutrition) in hospital and are at moderate or high risk of refeeding syndrome based on standard clinical guidelines. People whose IV nutrition is expected to last less than seven days, or who cannot provide consent, would not be eligible.

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Interventions

Thiamine replacement (b dose forte brand) 250mg daily intravenously for 7 days

Thiamine replacement (b dose forte brand) 250mg daily intravenously for 7 days


Locations(1)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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ACTRN12623000589684


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