Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
95 participants
INTERVENTIONAL
2018-09-04
2022-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Thiamine
200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)
Thiamine Hydrochloride
Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.
Placebo
Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)
Placebo
50ml of 0.9% NACL will serve as the placebo
Interventions
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Thiamine Hydrochloride
Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.
Placebo
50ml of 0.9% NACL will serve as the placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)
3. Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)
4. Serum lactate ≥2mmol/L
5. Creatinine \>1.0mg/dL
Exclusion Criteria
2. Renal replacement therapy within the past 30 days
3. Comfort measures only or anticipated withdrawal of support within 24 hours
4. Protected populations (pregnant women, prisoners)
5. Known thiamine allergy
18 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Michael Donnino
Associate Professor of Emergency Medicine
Principal Investigators
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Ari Moskowitz, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Northshore University Hospital
Manhasset, New York, United States
Montefiore Medical Center
New York, New York, United States
Long Island Jewish Hospital
Queens, New York, United States
Countries
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References
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Moskowitz A, Andersen LW, Cocchi MN, Karlsson M, Patel PV, Donnino MW. Thiamine as a Renal Protective Agent in Septic Shock. A Secondary Analysis of a Randomized, Double-Blind, Placebo-controlled Trial. Ann Am Thorac Soc. 2017 May;14(5):737-741. doi: 10.1513/AnnalsATS.201608-656BC.
Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, Wolfe R, Moskowitz A, Smithline H, Ngo L, Cocchi MN; Center for Resuscitation Science Research Group. Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study. Crit Care Med. 2016 Feb;44(2):360-7. doi: 10.1097/CCM.0000000000001572.
Vine J, Lee JH, Kravitz MS, Grossestreuer AV, Balaji L, Leland SB, Berlin N, Moskowitz A, Donnino MW. Thiamine administration in septic shock: a post hoc analysis of two randomized trials. Crit Care. 2024 Feb 6;28(1):41. doi: 10.1186/s13054-024-04818-1.
Moskowitz A, Berg KM, Grossestreuer AV, Balaji L, Liu X, Cocchi MN, Chase M, Gong MN, Gong J, Parikh SM, Ngo L, Berlin N, Donnino MW. Thiamine for Renal Protection in Septic Shock (TRPSS): A Randomized, Placebo-controlled, Clinical Trial. Am J Respir Crit Care Med. 2023 Sep 1;208(5):570-578. doi: 10.1164/rccm.202301-0034OC.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018P-000204
Identifier Type: -
Identifier Source: org_study_id
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