SepsisPhase 2NCT03550794
Thiamine as a Renal Protective Agent in Septic Shock
A Phase 2 study testing Thiamine Hydrochloride in people with Sepsis and Kidney Injury, run by Beth Israel Deaconess Medical Center at 4 sites in United States.
Trial summary
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Kidney Injury, Thiamine Deficiency
- What is being tested?
- Thiamine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Sep 2018to 5 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥18 years of age
- Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)
- Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)
- Serum lactate ≥2mmol/L
- Creatinine >1.0mg/dL
Who cannot join
- Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
- Renal replacement therapy within the past 30 days
- Comfort measures only or anticipated withdrawal of support within 24 hours
- Protected populations (pregnant women, prisoners)
- Known thiamine allergy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Northshore University Hospital
Manhasset, New York, 11030
Montefiore Medical Center
New York, New York, 10467
Long Island Jewish Hospital
Queens, New York, 11040
About this study
Official title: Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.
Read the detailed description
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal injury in septic shock. Patients admitted with septic shock who have a lactate of at least 2.0mmol/L and do not have pre-existing renal failure requiring dialysis will be eligible for the study. Enrolled patients will be randomized to intravenous thiamine 200mg twice daily for 6 doses or matching placebo. Blood will be drawn at several time points to assess biomarkers of renal injury. Secondary endpoints include need for renal replacement therapy, length of ICU stay, and hospital mortality.
- Conditions
- Sepsis, Kidney Injury, Thiamine Deficiency
- Being tested
- Thiamine Hydrochloride, Placebo
- Medical subject headings
- Sepsis, Thiamine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiamine HydrochlorideDrug
Also called Thiamine, Vitamin B1
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.
PlaceboDrug
Also called Normal Saline, 0.9%NACL
50ml of 0.9% NACL will serve as the placebo
| Study group | Role | What they receive |
|---|---|---|
| Thiamine | Experimental | 200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses) Receives: Drug: Thiamine Hydrochloride |
| Placebo | Placebo comparator | Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney Injury Biomarker
Change in creatinine over time
Measured: Enrollment to 72-hours
Secondary outcomes (8)
Number of Participants Receiving Renal Replacement Therapy
Number of participants who received renal replacement therapy in thiamine and placebo groups.
Measured: 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
ICU Free Days
Days alive and free of the ICU through day 28
Measured: From date of enrollment until 28 days after enrollment
In-hospital Mortality
Length of hospital stay truncated at 60 days
Measured: From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment
Number of Participants Experiences Acute Renal Failure
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).
Measured: 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
Change in Lactate Level
Change in lactate level between enrollment and 72 hours after enrollment
Measured: From time of enrollment until 72 hours after enrollment
Number of Participants With Delirium on Day 3
Number of Participants with Delirium on Day 3 after enrollment
Measured: Day 3 after enrollment
Change in the Sequential Organ Failure Assessment Score
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.
Measured: Time of enrollment until 72 hours after enrollment
Novel Biomarkers of Renal Injury
KIM-1, NGAL, Cystatin-C at 24-hours after enrollment
Measured: 24 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start4 Sep 2018
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Donnino, Beth Israel Deaconess Medical Center
- Investigators
- Ari Moskowitz, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550794
- Sponsor's protocol ID
- 2018P-000204
- Status last verified
- Jun 2023
- First submitted
- 25 May 2018
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28207287Donnino 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.
PubMed 26771781Leland S, Bank H, Shvilkina T, Lee JH, Berlin N, Peitzman C, Zubair MM, Moskowitz A, Donnino MW, Grossestreuer AV. Impact of the updated SOFA-2 score on organ dysfunction assessment and trial outcomes in Sepsis: A reanalysis of two randomized trials. J Crit Care. 2026 Nov 4;97:155809. doi: 10.1016/j.jcrc.2026.155809. Online ahead of print.
PubMed 42981694Vine 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.
PubMed 38321529Moskowitz 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.
PubMed 37364280
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03550794
- Acronym / sponsor ID
- 2018P-000204
- Conditions
- Sepsis, Kidney Injury, Thiamine Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Posted 27 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.
Detailed description
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal injury in septic shock. Patients admitted with septic shock who have a lactate of at least 2.0mmol/L and do not have pre-existing renal failure requiring dialysis will be eligible for the study. Enrolled patients will be randomized to intravenous thiamine 200mg twice daily for 6 doses or matching placebo. Blood will be drawn at several time points to assess biomarkers of renal injury. Secondary endpoints include need for renal replacement therapy, length of ICU stay, and hospital mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiamine | Experimental | Drug: Thiamine Hydrochloride200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses) |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult ≥18 years of age
- Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)
- Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)
- Serum lactate ≥2mmol/L
- Creatinine >1.0mg/dL
Key exclusion criteria (5 listed)
- Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
- Renal replacement therapy within the past 30 days
- Comfort measures only or anticipated withdrawal of support within 24 hours
- Protected populations (pregnant women, prisoners)
- Known thiamine allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thiamine HydrochlorideAlso: Thiamine, Vitamin B1Thiamine 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. | Drug | Thiamine |
| PlaceboAlso: Normal Saline, 0.9%NACL50ml of 0.9% NACL will serve as the placebo | Drug | Placebo |
Primary outcome
Kidney Injury Biomarker
Time frame: Enrollment to 72-hours
Change in creatinine over time
8 secondary outcomes
Number of Participants Receiving Renal Replacement Therapy
Time frame: 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
ICU Free Days
Time frame: From date of enrollment until 28 days after enrollment
In-hospital Mortality
Time frame: From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment
Number of Participants Experiences Acute Renal Failure
Time frame: 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
Change in Lactate Level
Time frame: From time of enrollment until 72 hours after enrollment
Number of Participants With Delirium on Day 3
Time frame: Day 3 after enrollment
Change in the Sequential Organ Failure Assessment Score
Time frame: Time of enrollment until 72 hours after enrollment
Novel Biomarkers of Renal Injury
Time frame: 24 hours after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28207287Moskowitz 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.
- Background: PubMed 26771781Donnino 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.
- Derived from this study: PubMed 42981694Leland S, Bank H, Shvilkina T, Lee JH, Berlin N, Peitzman C, Zubair MM, Moskowitz A, Donnino MW, Grossestreuer AV. Impact of the updated SOFA-2 score on organ dysfunction assessment and trial outcomes in Sepsis: A reanalysis of two randomized trials. J Crit Care. 2026 Nov 4;97:155809. doi: 10.1016/j.jcrc.2026.155809. Online ahead of print.
- Derived from this study: PubMed 38321529Vine 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.
- Derived from this study: PubMed 37364280Moskowitz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari Moskowitz, MD principal investigator
Beth Israel Deaconess Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thiamine Hydrochloride in people with Sepsis and Kidney Injury, run by Beth Israel Deaconess Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney Injury Biomarker (time frame: Enrollment to 72-hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03550794, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.