Trial · NCT03550794
Thiamine as a Renal Protective Agent in Septic Shock
NCT03550794, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2023-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Thiamine as a Renal Protective Agent in Septic Shock. Trials, record NCT03550794. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03550794
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thiamine as a Renal Protective Agent in Septic Shock
- NCT number
- NCT03550794
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 95 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Sepsis, Kidney Injury, Thiamine Deficiency
- Interventions
- Thiamine Hydrochloride, Placebo
- First posted
- 2018-06-08
- Last updated
- 2023-06-27
- Results first posted
- 2023-06-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kidney Injury Biomarker | Enrollment to 72-hours | Change in creatinine over time |
| Secondary | Number of Participants Receiving Renal Replacement Therapy | 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. |
| Secondary | ICU Free Days | From date of enrollment until 28 days after enrollment | Days alive and free of the ICU through day 28 |
| Secondary | In-hospital Mortality | 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 |
| Secondary | Number of Participants Experiences Acute Renal Failure | 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). |
| Secondary | Change in Lactate Level | From time of enrollment until 72 hours after enrollment | Change in lactate level between enrollment and 72 hours after enrollment |
| Secondary | Number of Participants With Delirium on Day 3 | Day 3 after enrollment | Number of Participants with Delirium on Day 3 after enrollment |
| Secondary | Change in the Sequential Organ Failure Assessment Score | 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. |
| Secondary | Novel Biomarkers of Renal Injury | 24 hours after enrollment | KIM-1, NGAL, Cystatin-C at 24-hours after enrollment |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kidney Injury Biomarker | Enrollment to 72-hours | mg/dL | MEAN | |
| SECONDARY | Number of Participants Receiving Renal Replacement Therapy | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ICU Free Days | From date of enrollment until 28 days after enrollment | days | MEDIAN | |
| SECONDARY | In-hospital Mortality | From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiences Acute Renal Failure | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Lactate Level | From time of enrollment until 72 hours after enrollment | mmol/L | MEDIAN | |
| SECONDARY | Number of Participants With Delirium on Day 3 | Day 3 after enrollment | Excludes 8 and 4 patients in intervention and placebo groups with delirium status unable to assess | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in the Sequential Organ Failure Assessment Score | Time of enrollment until 72 hours after enrollment | units on a scale | MEAN | |
| SECONDARY | Novel Biomarkers of Renal Injury | 24 hours after enrollment | A total of 32 patients in thiamine and 37 patients in placebo had biomarkers available at both 0 hours and 24 hours and thus contributed to the model estimates | pg/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kidney Injury Biomarker | Thiamine | 2.24 | Standard Deviation 1.50 | mg/dL | |
| Kidney Injury Biomarker | Placebo | 2.79 | Standard Deviation 1.91 | mg/dL | |
| Number of Participants Receiving Renal Replacement Therapy | Thiamine | 6 | Participants | ||
| Number of Participants Receiving Renal Replacement Therapy | Placebo | 10 | Participants | ||
| ICU Free Days | Thiamine | 22.5 | Inter-Quartile Range 0.0 to 25.0 | days | |
| ICU Free Days | Placebo | 0.0 | Inter-Quartile Range 0.0 to 23.0 | days | |
| In-hospital Mortality | Thiamine | 15 | Participants | ||
| In-hospital Mortality | Placebo | 25 | Participants | ||
| Number of Participants Experiences Acute Renal Failure | Thiamine | 23 | Participants | ||
| Number of Participants Experiences Acute Renal Failure | Placebo | 34 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Thiamine | 46 | |
| Overall Study | STARTED | Placebo | 49 | |
| Overall Study | COMPLETED | Thiamine | 42 | |
| Overall Study | COMPLETED | Placebo | 46 | |
| Overall Study | NOT COMPLETED | Thiamine | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thiamine | 15 | 42 |
| Total, all-cause mortality | Placebo | 25 | 46 |
| Total, other adverse events | Thiamine | 0 | 42 |
| Total, other adverse events | Placebo | 0 | 46 |
| Total, serious adverse events | Thiamine | 0 | 42 |
| Total, serious adverse events | Placebo | 0 | 46 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Thiamine vs Placebo: Number of Participants Receiving Renal Replacement Therapy | Trial comparisons |
| Thiamine vs Placebo: Number of Participants Experiences Acute Renal Failure | Trial comparisons |
| Thiamine vs Placebo: In-hospital Mortality | Trial comparisons |
| Thiamine vs Placebo: deaths from any cause | Trial comparisons |
| Thiamine vs Placebo: Number of Participants With Delirium on Day 3 | Trial comparisons |
| Thiamine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03550794
GET https://conductscience.org/api/trials/v1/NCT03550794/results?page=2