NCT03550794

Thiamine as a Renal Protective Agent in Septic Shock

Completed Phase 2 Results posted Last updated 27 June 2023

What this trial tests

Phase 2 trial testing Thiamine Hydrochloride in Sepsis in 95 participants. Completed in 5 April 2022.

Timeline

4 September 2018

Primary endpoint
5 April 2022

5 April 2022

Quick facts

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	95
Start date	4 September 2018
Primary completion	5 April 2022
Estimated completion	5 April 2022
Sites	4 locations across United States

Drugs / interventions tested

• Thiamine Hydrochloride (THIAMINE) — full drug profile →
• Placebo

Conditions studied

• Sepsis — all drugs for Sepsis →
• Kidney Injury — all drugs for Kidney Injury →
• Thiamine Deficiency — all drugs for Thiamine Deficiency →

Sponsor

Beth Israel Deaconess Medical Center

Who can join

18 and older, any sex, with Sepsis or Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Kidney Injury Biomarker Primary · Enrollment to 72-hours

Change in creatinine over time

Group	Value	95% CI
Thiamine	2.24	± 1.50
Placebo	2.79	± 1.91

Number of Participants Receiving Renal Replacement Therapy Secondary · From date of enrollment until discharge from the intensive care unit (ICU) or date of death, whichever comes first, up to 60 days after enrollment

Number of participants who received renal replacement therapy in thiamine and placebo groups.

Group	Value	95% CI
Thiamine	6
Placebo	10

ICU Free Days Secondary · From date of enrollment until 28 days after enrollment

Days alive and free of the ICU through day 28

Group	Value	95% CI
Thiamine	22.5	0.0 – 25.0
Placebo	0.0	0.0 – 23.0

In-hospital Mortality Secondary · From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment

Length of hospital stay truncated at 60 days

Group	Value	95% CI
Thiamine	15
Placebo	25

Number of Participants Experiences Acute Renal Failure Secondary · From date of enrollment until day of discharge from the index ICU admission or date of death, whichever comes first up until 60 days post-enrollment

Acute renal failure as defined by the KDIGO (Kidney Disease Improving Global Outcomes) AKI (Acute Kidney Injury) criteria. In brief, a patient can meet these criteria if their serum creatinine increases (for example, serum creatinine increases to 1.5x or higher of baseline serum creatinine, or if it crosses 4mg/dL), or if renal replacement therapy is initiated, or if urine output decreases (for example, \<0.5ml/kg/hour for 6-12 hours) or if patient becomes anuric (no urine production).

Group	Value	95% CI
Thiamine	23
Placebo	34

Change in Lactate Level Secondary · From time of enrollment until 72 hours after enrollment

Change in lactate level between enrollment and 72 hours after enrollment

Group	Value	95% CI
Thiamine	1.65	1.10 – 2.80
Placebo	1.95	1.40 – 2.30

Number of Participants With Delirium on Day 3 Secondary · Day 3 after enrollment

Number of Participants with Delirium on Day 3 after enrollment

Group	Value	95% CI
Thiamine	25
Placebo	30

Change in the Sequential Organ Failure Assessment Score Secondary · Time of enrollment until 72 hours after enrollment

Change in Sequential Organ Failure Assessment Score (SOFA) score between enrollment and 72 hours after enrollment. SOFA scores are reported on a scale between 0-24, with 0 representing best outcome and 24 representing worst outcome.

Group	Value	95% CI
Thiamine	8.09	± 5.60
Placebo	9.61	± 5.96

Novel Biomarkers of Renal Injury Secondary · 24 hours after enrollment

KIM-1, NGAL, Cystatin-C at 24-hours after enrollment

KIM-1

Group	Value	95% CI
Thiamine	763.1	454.8 – 1504.8
Placebo	793.9	350.6 – 1548.8

NGAL

Group	Value	95% CI
Thiamine	1067898.2	501797.2 – 1528804.4
Placebo	1558285.0	966335.0 – 3235305.6

Cystatin

Group	Value	95% CI
Thiamine	1689158.2	1238353.1 – 2677488.6
Placebo	2183175.4	1614104.4 – 2819738.6

Sponsor's own description

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Thiamine (vitamin B1) in septic shock: a targeted therapy.
   Moskowitz A, Donnino MW. · · 2020 · cited 37× · PMID 32148929 · DOI 10.21037/jtd.2019.12.82
2. Thiamine for Renal Protection in Septic Shock (TRPSS): A Randomized, Placebo-controlled, Clinical Trial.
   Moskowitz A, Berg KM, Grossestreuer AV, Balaji L, et al · · 2023 · cited 18× · PMID 37364280 · DOI 10.1164/rccm.202301-0034oc
3. Thiamine administration in septic shock: a post hoc analysis of two randomized trials.
   Vine J, Lee JH, Kravitz MS, Grossestreuer AV, et al · · 2024 · cited 15× · PMID 38321529 · DOI 10.1186/s13054-024-04818-1
4. The Impact of Extended-Hours Patient Recruitment on Critical Care Clinical Trial Enrollment.
   Lee JH, Vine J, Meier M, Berkovitz A, et al · · 2025 · PMID 40138529 · DOI 10.1097/cce.0000000000001239
5. Thiamine administration in septic shock: towards finding the target population.
   Vine J, Lee JH, Moskowitz A, Donnino MW. · · 2024 · PMID 39695817 · DOI 10.1186/s13054-024-05209-2