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This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.
This is a multi-site, randomized, double-blind, placebo-controlled trial comparing a regimen of moderate-dose (6000 mg per day) Vitamin C supplementation versus placebo for the treatment of patients presenting to the ICU with septic shock. Both groups will continue to receive all other standard of care measures for septic shock as clinically indicated. Groups will be enrolled and receive study drug/placebo for 4 days (96 hours) or until 24 hours post-last pressor dose, whichever is sooner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Sham Comparator | Placebo designed to mimic intervention |
|
| Intervention | Active Comparator | 6000 mg per day Vitamin C supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | Continuous infusion of vitamin C |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ICU Mortality | Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU). | 28 days |
| All Cause Mortality at 28 Days | Outcome is reported as the number of participants who have expired at 28 days post intervention | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Vasopressor Therapy | Outcome is reported as the duration in hours of vasopressor therapy post intervention administration | 28 days |
| Duration of ICU Stay Post Intervention Administration |
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Inclusion Criteria:
• Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.
Age ≥ 18 years
Septic shock as pragmatically defined as:
o Order for intravenous antimicrobials with either procalcitonin > 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND
Hypotension requiring vasopressor therapy, despite fluid resuscitation of at least 30 cc/kg AND
Lactate > 2 mmol/L 24 hr prior to enrollment AND
Presence of sepsis defined as equal to or greater than 2 SIRS criteria and/or acute increase in qSOFA score of 2 points or more.
Exclusion Criteria:
• Unable to start infusion within 24 hours of septic shock identification
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34982738 | Derived | Wacker DA, Burton SL, Berger JP, Hegg AJ, Heisdorffer J, Wang Q, Medcraft EJ, Reilkoff RA. Evaluating Vitamin C in Septic Shock: A Randomized Controlled Trial of Vitamin C Monotherapy. Crit Care Med. 2022 May 1;50(5):e458-e467. doi: 10.1097/CCM.0000000000005427. Epub 2022 Jan 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo designed to mimic intervention Placebo: Placebo designed to mimic intervention |
| FG001 | Intervention | Vitamin C Vitamin C: Continuous infusion of vitamin C |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo designed to mimic intervention Placebo: Placebo designed to mimic intervention |
| BG001 | Intervention | Vitamin C Vitamin C: Continuous infusion of vitamin C |
| 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 | Number of Participants With ICU Mortality | Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU). | Posted | Count of Participants | Participants | 28 days |
|
|
28 days
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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 | Placebo designed to mimic intervention Placebo: Placebo designed to mimic intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Troponin w/o ST elevation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose stools | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Reilkoff, MD | University of Minnesota | 612-624-0999 | rreilkof@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2020 | Jul 7, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2020 | Jul 13, 2021 | ICF_002.pdf |
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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 |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo designed to mimic intervention |
|
Outcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration
| 28 days |
| Time to Lactate Clearance Post Intervention Administration | 28 days |
| Rate of Lactate Clearance Post Intervention Administration | Outcome is reported as the number of participants who clear lactate from the bloodstream at 24, 48, 72, and 96 hours post intervention. Clearance is defined as a serum concentration of 2.0 mmol/l or less. | 24, 48, 72, and 96 hours post intervention |
| Rate of Procalcitonin Clearance Post Intervention Administration | 4 days |
| Number of Participants With Need for Renal Replacement Therapy | Outcome is reported as the number of participants who require renal replacement therapy | 4 days |
| Change in Serum Creatinine | Outcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl. | Baseline and 4 days |
| Change in Sequential Organ Failure Assessment (SOFA) Score | SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems. Total scores range from 0 to 24, with higher scores indicating higher likely mortality. | Baseline and 4 days |
| Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores | APACHE score is a severity-of-disease classification system that is calculated from a patient's age and 12 routine physiological measurements. Total scores are computed based on several measurements and range from 0 to 71 with higher scores corresponding to more severe disease and a higher risk of death. | Baseline and 4 days |
| Total Intravenous Fluid Administered | Outcome is reported as the total volume of intravenous fluid (in liters) administered to participants during 24 hours following the initiation of study treatment. | 24 hours |
| Lost to Follow-up |
|
| 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 |
|
| Participants |
|
|
| Primary | All Cause Mortality at 28 Days | Outcome is reported as the number of participants who have expired at 28 days post intervention | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Duration of Vasopressor Therapy | Outcome is reported as the duration in hours of vasopressor therapy post intervention administration | Posted | Median | Inter-Quartile Range | hours | 28 days |
|
|
|
| Secondary | Duration of ICU Stay Post Intervention Administration | Outcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration | Posted | Mean | Inter-Quartile Range | days | 28 days |
|
|
|
| Secondary | Time to Lactate Clearance Post Intervention Administration | Measure was not collected | Posted | 28 days |
|
|
| Secondary | Rate of Lactate Clearance Post Intervention Administration | Outcome is reported as the number of participants who clear lactate from the bloodstream at 24, 48, 72, and 96 hours post intervention. Clearance is defined as a serum concentration of 2.0 mmol/l or less. | All participants who completed 96 hours of testing are included. | Posted | Count of Participants | Participants | 24, 48, 72, and 96 hours post intervention |
|
|
|
| Secondary | Rate of Procalcitonin Clearance Post Intervention Administration | Outcome was not collected. | Posted | 4 days |
|
|
| Secondary | Number of Participants With Need for Renal Replacement Therapy | Outcome is reported as the number of participants who require renal replacement therapy | Posted | Count of Participants | Participants | 4 days |
|
|
|
| Secondary | Change in Serum Creatinine | Outcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl. | All participants for whom baseline and 96-hour creatinine data is available are included in this analysis. | Posted | Median | Inter-Quartile Range | mg/dl | Baseline and 4 days |
|
|
|
| Secondary | Change in Sequential Organ Failure Assessment (SOFA) Score | SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems. Total scores range from 0 to 24, with higher scores indicating higher likely mortality. | All participants for whom baseline and 96-hour SOFA scores were available are included in this analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 4 days |
|
|
|
| Secondary | Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores | APACHE score is a severity-of-disease classification system that is calculated from a patient's age and 12 routine physiological measurements. Total scores are computed based on several measurements and range from 0 to 71 with higher scores corresponding to more severe disease and a higher risk of death. | All participants for whom APACHE scores at baseline and 4 days post intervention were available are included. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline and 4 days |
|
|
|
| Secondary | Total Intravenous Fluid Administered | Outcome is reported as the total volume of intravenous fluid (in liters) administered to participants during 24 hours following the initiation of study treatment. | All participants for whom total intravenous fluid administration data was available are included. | Posted | Mean | Inter-Quartile Range | liters | 24 hours |
|
|
|
| 26 |
| 64 |
| 3 |
| 64 |
| 9 |
| 64 |
| EG001 | Intervention | Vitamin C Vitamin C: Continuous infusion of vitamin C | 16 | 61 | 4 | 61 | 8 | 61 |
| New or worsening heart failure | Cardiac disorders | Systematic Assessment |
|
| Arrythmia | Cardiac disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| New or worsening heart failure | Cardiac disorders | Systematic Assessment |
|
| Arrythmia | Cardiac disorders | Systematic Assessment |
|
| Elevated Troponin w/o ST elevation | Cardiac disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Maculopapular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| 72 hours |
|
| 96 hours |
|