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PI's add. responsibilities and time commitment prevent him from completing trial
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The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.
It has been shown that the stress that occurs during trauma, infection and/or shock depletes many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to further complications. The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascorbic Acid | Active Comparator | Ascorbic Acid |
|
| Ringers Lactate or Normal Saline | Placebo Comparator | Ringers Lactate or Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic Acid | Drug | 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of High Dose Vitamin C Therapy in Shock Patients | Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicente Gracias, MD | RWJMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ascorbic Acid | Ascorbic Acid Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams |
| FG001 | Placebo | Ringers Lactate or Normal Saline Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ascorbic Acid | Ascorbic Acid Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams |
| BG001 | Ringers Lactate or Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Efficacy of High Dose Vitamin C Therapy in Shock Patients | Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock. | Study terminated prior to data collection completion. No data analysis performed. | Posted | 30 days |
|
Subjects will be randomized to receive high dose Vitamin C or placebo for 24 hours. The study team will follow the subjects and collect data through hospital discharge or 28 days whichever occurs first.
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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 | Ascorbic Acid | Ascorbic Acid Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams |
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Early termination leading to small number of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vincente Gracias | Rutgers RWJMS | 732-235-7920 | graciavh@rwjms.rutgers.edu |
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| ID | Term |
|---|---|
| D012769 | Shock |
| D020896 | Hypovolemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000077325 | Ringer's Lactate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ringers Lactate or Normal Saline | Other | Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour. |
|
|
Ringers Lactate or Normal Saline
Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Ringers Lactate or Normal Saline Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour. |
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Ringers Lactate or Normal Saline | Ringers Lactate or Normal Saline Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour. | 0 | 4 | 0 | 4 |
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| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |