Evidence map›Paper›PMID 33945982›Full record

Trial reportJournal of psychosomatic research2021

A randomized double-blind placebo-controlled trial of intravenous thiamine for prevention of delirium following allogeneic hematopoietic stem cell transplantation.

Zev M Nakamura, Allison M Deal, Eliza M Park, Laura J Quillen, Stephanie A Chien, Kate E Stanton, Sean D McCabe, Hillary M Heiling, William A Wood, Thomas C Shea and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of psychosomatic research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03263442 (Randomized Placebo Controlled Trial of High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03263442 phase2completednot on this map

Randomized Placebo Controlled Trial of High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation

TypeinterventionalSponsorUNC Lineberger Comprehensive Cancer CenterRan2017 to 2020Enrolled66ConditionsHematopoietic Stem Cell Transplantation, Delirium, Thiamine DeficiencyArmsThiamine, Normal saline
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Zev M NakamuraDepartment of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: zev_nakamura@med.unc.edu.
Allison M DealLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Eliza M ParkDepartment of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Laura J QuillenDepartment of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Stephanie A ChienDepartment of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Kate E StantonLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Sean D McCabeDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Hillary M HeilingDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
William A WoodLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Thomas C SheaLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Donald L RosensteinDepartment of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
University of North Carolina at Chapel Hill · US

Funding

UNC BIRCWH CAREER DEVELOPMENT PROGRAMK12HD001441 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BOGGESS, KIM A · 2000 to 2019
$9.3M
Biostatistics for Research in Genomics and CancerT32CA106209 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOSEPH G IBRAHIM, Naim Ur Rashid · 2004 to 2026
$4.8M
A Psychosocial Intervention to Improve Outcomes for Parents with Advanced CancerK07CA218167 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI PARK, ELIZA MYUNG · 2017 to 2021
$884k
NCI NIH HHS K07 CA218167NCI NIH HHS T32 CA106209NICHD NIH HHS K12 HD001441
6 · The paper itself

Abstract

objectiveTo determine if high dose intravenous (IV) thiamine can prevent delirium during hospitalization following allogeneic HSCT. Secondarily, we evaluated the effects of high dose IV thiamine on thiamine levels and explored risk factors for delirium.

methodsRandomized, double-blind, placebo-controlled trial in patients undergoing allogeneic HSCT at a U.S. academic medical center between October 2017 and March 2020. 64 participants were randomized 1:1 to thiamine 200 mg IV three times daily for 7 days or placebo. We used the Delirium Rating Scale to assess for delirium. Delirium incidence was compared between groups using the chi-square test. Group differences in time to onset and duration of delirium were compared using the Kaplan-Meier method. Fisher's Exact and Wilcoxon Rank Sum tests were used to examine associations between pre-transplantation variables and delirium.

results61 participants were analyzed. Delirium incidence (25% vs. 21%, Chi-square (df = 1) = 0.12, p = 0.73), time to onset, duration, and severity were not different between study arms. Immediately following the intervention, thiamine levels were higher in the thiamine arm (275 vs. 73 nmol/L, t-test (df = 57) = 13.63, p < 0.0001), but not predictive of delirium. Variables associated with delirium in our sample included disease severity, corticosteroid exposure, infection, and pre-transplantation markers of nutrition.

conclusionHigh dose IV thiamine did not prevent delirium in patients receiving allogeneic HSCT. Given the multiple contributors to delirium in this population, further research regarding the efficacy of multicomponent interventions may be needed.

trial registrationClinical Trials NCT03263442.

fundingRising Tide Foundation for Clinical Cancer Research.

Indexed as

DeliriumHematopoietic Stem Cell TransplantationAdministration, IntravenousDouble-Blind MethodHumansThiamineThiamineCognitive impairmentDeliriumHematopoietic stem cell transplantationThiamineWernicke-Korsakoff syndromeWernicke's encephalopathy

Identifiers

PMID33945982
PMCPMC8172461
OpenAlexW3158964982

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.