Evidence map›Paper›PMID 26771781›Full record

Trial reportCritical care medicine2016

Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study.

Michael W Donnino, Lars W Andersen, Maureen Chase, Katherine M Berg, Mark Tidswell, Tyler Giberson, Richard Wolfe, Ari Moskowitz, Howard Smithline, Long Ngo and 2 more

10 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 10 registered trials, which are not on this map. Cited by 118 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
118citing papers in PubMed, 8 pooled it
20.0field-weighted citation impact, top 1% 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.

NCT03335124 phase4terminatednot on this mapstarted 2017, after this paper: background citation

A Randomized, Double Blind, Placebo-Controlled Study to Investigate the Effects of Vitamin C, Hydrocortisone and Thiamine on the Outcome of Patients With Severe Sepsis and Septic Shock

TypeinterventionalSponsorUniversity Medical Centre LjubljanaRan2017 to 2018Enrolled5ConditionsSepsis, Septic Shock, Critical Illness, Fluid OverloadArmsVitamin C, Hydrocortisone, Thiamine, 0.9% Sodium Chloride Injection
NCT03380507 phase2 / phase3terminatednot on this mapstarted 2018, after this paper: background citation

Evaluation of Hydrocortisone, Vitamin C and Thiamine for the Treatment of Septic Shock

TypeinterventionalSponsorHamad Medical CorporationRan2018 to 2021Enrolled106ConditionsSeptic Shock, Critical IllnessArmsTriple therapy group
NCT03389555 phase2 / phase3completednot on this mapstarted 2018, after this paper: background citation

Ascorbic Ccid, Hydrocortisone, and Thiamine in Sepsis and Septic Shock - A Randomized, Double-Blind, Placebo-Controlled Trial

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2018 to 2020Enrolled205ConditionsSepsis, Septic Shock, Metabolic DisturbanceArmsvitamin C, vitamin B1, hydrocortisone, Normal saline
NCT03422159 phase2completednot on this mapstarted 2018, after this paper: background citation

Outcomes of Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in the Early Treatment of Sepsis.

TypeinterventionalSponsorCommunity Medical Center, Toms River, NJRan2018 to 2019Enrolled140ConditionsSepsis, Severe, Septic ShockArmsAscorbic Acid, Thiamine, Hydrocortisone, Sodium Chloride 0.9%
NCT03550794 phase2completednot on this mapstarted 2018, after this paper: background citation

Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2018 to 2022Enrolled95ConditionsSepsis, Kidney Injury, Thiamine DeficiencyArmsThiamine Hydrochloride, Placebo
NCT03756220 phase2completednot on this mapstarted 2018, after this paper: background citation

Combination Therapy of Vitamin C and Thiamine for Septic Shock: Multi-center, Double-blinded, Randomized, Controlled Study

TypeinterventionalSponsorTae Gun ShinRan2018 to 2020Enrolled116ConditionsSeptic Shock, SepsisArmsCombination therapy of vitamin C and thiamine, Normal saline solution
NCT04641104 phase4completednot on this mapstarted 2020, after this paper: background citation

The Thiamine Administration After Cardiac Surgery Trial

TypeinterventionalSponsorSarah SaxenaRan2020 to 2022Enrolled200ConditionsLactate Blood Increase, Thiamine DeficiencyArmsThiamine 500 MG, Placebo
NCT05840718 completednot on this mapstarted 2023, after this paper: background citation

Impact of Thiamine Supplementation on Clinical Outcomes of Patients With Septic Shock: a Retrospective Before-after Study

TypeobservationalSponsorHospital Sao DomingosRan2023 to 2023Enrolled73ConditionsSeptic ShockArmsThiamin
NCT06322212 early_phase1recruitingnot on this mapstarted 2024, after this paper: background citation

Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical Trial

TypeinterventionalSponsorUniversity of California, Los AngelesRan2024 to 2027Enrolled52ConditionsType2diabetesArmsThiamine, Placebo
NCT06326996 early_phase1recruitingnot on this mapstarted 2024, after this paper: background citation

Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical Trial.

TypeinterventionalSponsorUniversity of California, Los AngelesRan2024 to 2026Enrolled52ConditionsCoronary Heart Disease, Coronary Artery Bypass GraftingArmsThiamine, Placebo
3 · Its place in the literature

Who cites it

118 citing papers in PubMed, 8 syntheses or guidelines pooled it, 282 citations in OpenAlex.

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58 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 1 institution in 2 countries.

Michael W Donnino1Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA. 2Department of Medicine, Division of Pulmonary and Critical Care, Beth Israel Deaconess Medical Center, Boston, MA. 3Department of Anesthesiology, Aarhus University Hospital, Aarhus, Denmark. 4Department of Medicine, Division of Pulmonary and Critical Care, Baystate Medical Center, MA. 5Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, MA. 6Department of Emergency Medicine, Baystate Medical Center, MA. 7Department of Anesthesia Critical Care, Division of Critical Care, Beth Israel Deaconess Medical Center, Boston, MA.
Lars W Andersen
Maureen Chase
Katherine M Berg
Mark Tidswell
Tyler Giberson
Richard Wolfe
Ari Moskowitz
Howard Smithline
Long Ngo
Michael N Cocchi
Center for Resuscitation Science Research Group
Beth Israel Deaconess Medical Center · US

Funding

Statin Therapy in Acute InfluenzaK23GM101463 · NIGMS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI CHASE, MAUREEN · 2013 to 2017
$798k
Thiamine as a Metabolic Resuscitator in Septic ShockR21AT005119 · NCCIH · BETH ISRAEL DEACONESS MEDICAL CENTER · PI DONNINO, MICHAEL WILLIAM · 2010 to 2012
$734k
NCCIH NIH HHS 5R21AT005119NCCIH NIH HHS R21 AT005119NIGMS NIH HHS K23 GM101463
6 · The paper itself

Abstract

objectiveTo determine if intravenous thiamine would reduce lactate in patients with septic shock.

designRandomized, double-blind, placebo-controlled trial.

settingTwo US hospitals. PATIENTS: Adult patients with septic shock and elevated (> 3 mmol/L) lactate between 2010 and 2014.

interventionsThiamine 200 mg or matching placebo twice daily for 7 days or until hospital discharge. MEASUREMENTS AND MAIN

resultsThe primary outcome was lactate levels 24 hours after the first study dose. Of 715 patients meeting the inclusion criteria, 88 patients were enrolled and received study drug. There was no difference in the primary outcome of lactate levels at 24 hours after study start between the thiamine and placebo groups (median: 2.5 mmol/L [1.5, 3.4] vs. 2.6 mmol/L [1.6, 5.1], p = 0.40). There was no difference in secondary outcomes including time to shock reversal, severity of illness and mortality. 35% of the patients were thiamine deficient at baseline. In this predefined subgroup, those in the thiamine treatment group had statistically significantly lower lactate levels at 24 hours (median 2.1 mmol/L [1.4, 2.5] vs. 3.1 [1.9, 8.3], p = 0.03). There was a statistically significant decrease in mortality over time in those receiving thiamine in this subgroup (p = 0.047).

conclusionAdministration of thiamine did not improve lactate levels or other outcomes in the overall group of patients with septic shock and elevated lactate. In those with baseline thiamine deficiency, patients in the thiamine group had significantly lower lactate levels at 24 hours and a possible decrease in mortality over time.

Indexed as

AgedAged, 80 and overDouble-Blind MethodFemaleHumansLactic AcidMaleMiddle AgedPilot ProjectsSeverity of Illness IndexShock, SepticThiamineThiamine DeficiencyLactic AcidThiamine

Identifiers

PMID26771781
PMCPMC4754670
OpenAlexW2241408506

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

and 4 more above

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.