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Title: A multicenter randomized clinical trial of pharmacological vitamin B1 administration to critically ill patients who develop hypophosphatemia during enteral nutrition (The THIAMINE 4 HYPOPHOSPHATEMIA trial).
Austin Authors: Deane, Adam M;Jiang, Alice;Tascone, Brianna;Clancy, Annabelle;Finnis, Mark E;Collie, Jake T;Greaves, Ronda;Byrne, Kathleen M;Fujii, Tomoko;Douglas, James S;Nichol, Alistair;Udy, Andrew A;Young, Meredith;Russo, Giovanni;Fetterplace, Kate;Maiden, Matthew J;Plummer, Mark P;Yanase, Fumitaka ;Bellomo, Rinaldo ;Ali Abdelhamid, Yasmine
Affiliation: Intensive Care Unit, Barwon Health, Geelong, Australia
The University of Adelaide, Discipline of Acute Care Medicine, Adelaide, Australia
Victorian Clinical Genetics Services, Murdoch Children's Research Institute, Melbourne, Australia
Monash University, Department of Epidemiology and Preventive Medicine, Australian and New Zealand Intensive Care Research Centre, Melbourne, Australia
Intensive Care Unit, Royal Melbourne Hospital, Melbourne, Australia
RMIT University, School of Health and Biomedical Sciences, Melbourne, Australia
Department of Intensive Care, Western Health, Melbourne, Australia
Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, Australia
Intensive Care
School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland
The University of Melbourne, Department of Critical Care, Melbourne Medical School, Melbourne, Australia
Intensive Care Unit, Jikei University Hospital, Tokyo, Japan
Issue Date: Aug-2021
Date: 2021-07-24
Publication information: Clinical nutrition (Edinburgh, Scotland) 2021; 40(8): 5047-5052
Abstract: Hypophosphatemia may be a useful biomarker to identify thiamine deficiency in critically ill enterally-fed patients. The objective was to determine whether intravenous thiamine affects blood lactate, biochemical and clinical outcomes in this group. This randomized clinical trial was conducted across 5 Intensive Care Units. Ninety critically ill adult patients with a serum phosphate ≤0.65 mmol/L within 72 h of commencing enteral nutrition were randomized to intravenous thiamine (200 mg every 12 h for up to 14 doses) or usual care (control). The primary outcome was blood lactate over time and data are median [IQR] unless specified. Baseline variables were well balanced (thiamine: lactate 1.2 [1.0, 1.6] mmol/L, phosphate 0.56 [0.44, 0.64] mmol/L vs. control: lactate 1.0 [0.8, 1.3], phosphate 0.54 [0.44, 0.61]). Patients randomized to the intervention received a median of 11 [7.5, 13.5] doses for a total of 2200 [1500, 2700] mg of thiamine. Blood lactate over the entire 7 days of treatment was similar between groups (mean difference = -0.1 (95 % CI -0.2 to 0.1) mmol/L; P = 0.55). The percentage change from lactate pre-randomization to T = 24 h was not statistically different (thiamine: -32 (-39, -26) vs. control: -24 (-31, -16) percent, P = 0.09). Clinical outcomes were not statistically different (days of vasopressor administration: thiamine 2 [1, 4] vs. control 2 [0, 5.5] days; P = 0.37, and deaths 9 (21 %) vs. 5 (11 %); P = 0.25). In critically ill enterally-fed patients who developed hypophosphatemia, intravenous thiamine did not cause measurable differences in blood lactate or clinical outcomes. Australian and New Zealand Clinical Trials Registry (ACTRN12619000121167).
DOI: 10.1016/j.clnu.2021.07.024
Journal: Clinical Nutrition
PubMed URL: 34388414
Type: Journal Article
Subjects: Critical illness
Enteral nutrition
Lactic acidosis
Refeeding syndrome
Appears in Collections:Journal articles

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