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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | 50 ml D5W |
|
| 2 | Experimental | 200mg Thiamine in 50ml D5W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D5W | Drug | Dextrose 5% |
| |
| Thiamine |
| Measure | Description | Time Frame |
|---|---|---|
| Lactate Level 24 Hours After the First Study Medication Dose | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Shock Reversal | Shock reversal was defined as > 24 hours off all vasopressors | Hospital stay, average 2 weeks |
| APACHE II Score at 24 Hours | APACHE II ("Acute Physiology and Chronic Health Evaluation II") is a severity-of-disease classification system; an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death |
| Measure | Description | Time Frame |
|---|---|---|
| Lactate Level at 24 Hours in Patients With Baseline Thiamine Deficiency | Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L | 24 hours |
| Number of Participants Dying Before Hospital Discharge in Patients With Baseline Thiamine Deficiency |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W Donnino, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38321529 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 50 ml D5W D5W: Dextrose 5% |
| FG001 | Thiamine | 200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 50 ml D5W D5W: Dextrose 5% |
| BG001 | Thiamine | 200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lactate Level 24 Hours After the First Study Medication Dose | Posted | Median | Inter-Quartile Range | mmol/L | 24 hours |
|
|
Hospital stay, average 2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 50 ml D5W D5W: Dextrose 5% | 19 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael W Donnino | BIDMC | 617-754-2295 | mdonnino@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Drug |
Thiamine 200mg in 50ml D5W |
|
| 24 hours |
Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L |
| Hospital stay, average 2 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Number of Participants With Shock Reversal | Shock reversal was defined as > 24 hours off all vasopressors | Posted | Count of Participants | Participants | Hospital stay, average 2 weeks |
|
|
|
|
| Secondary | APACHE II Score at 24 Hours | APACHE II ("Acute Physiology and Chronic Health Evaluation II") is a severity-of-disease classification system; an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death | APACHE II was not available on 6 patients in each group at 24 hour mostly because of early death. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
|
| Other Pre-specified | Lactate Level at 24 Hours in Patients With Baseline Thiamine Deficiency | Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L | Posted | Median | Inter-Quartile Range | nmol/L | 24 hours |
|
|
|
|
| Other Pre-specified | Number of Participants Dying Before Hospital Discharge in Patients With Baseline Thiamine Deficiency | Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L | Posted | Count of Participants | Participants | Hospital stay, average 2 weeks |
|
|
|
|
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Thiamine | 200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5% | 19 | 43 | 0 | 43 | 0 | 43 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |