High Dose Vitamin C in the Critically Ill Patient (VitC)
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ClinicalTrials.gov Identifier: NCT01587963 |
Recruitment Status :
Terminated
(PI's add. responsibilities and time commitment prevent him from completing trial)
First Posted : April 30, 2012
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Shock | Drug: Ascorbic Acid Other: Ringers Lactate or Normal Saline | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | The Efficacy of High Dose Vitamin C in the Critically Ill Patient Population |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Ascorbic Acid
Ascorbic Acid
|
Drug: Ascorbic Acid
66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams
Other Name: Vit C |
Placebo Comparator: Ringers Lactate or Normal Saline
Ringers Lactate or Normal Saline
|
Other: 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.
Other Name: Placebo |
- Efficacy of High Dose Vitamin C Therapy in Shock Patients [ Time Frame: 30 days ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Activation of the Mass Transfusion Protocol following surgery or trauma.
- Diagnosis of septic shock. Septic shock will be defined as sepsis induced hypotension (i.e. systolic blood pressure <90mmHg or drop of systolic blood pressure >40mmHg in the presence of infection) that does not respond to a 2 liter fluid bolus.
Exclusion Criteria:
- Age less than 18 years.
- Pregnant women.
- Creatinine of greater than 2.2 g/dl at time of enrollment, history of chronic kidney or end stage renal disease, rise in creatinine > 1 g/dl within 24 hours prior to enrollment.
- Brain death diagnosed within 4 hours of presentation to the trauma bay or intensive care unit
- Patients with history of hemolytic blood disease, e.g. glucose-6-phosphate dehydrogenase deficiency, Sickle Cell Disease and Thalassemia.
- Patients in isolated cardiogenic shock.
- History of liver cirrhosis
- Transplant patients (liver, kidney, heart)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587963
United States, New Jersey | |
Robert Wood Johnson University Hospital | |
New Brunswick, New Jersey, United States, 08901 |
Principal Investigator: | Vicente Gracias, MD | RWJMS |
Responsible Party: | Rutgers, The State University of New Jersey |
ClinicalTrials.gov Identifier: | NCT01587963 |
Other Study ID Numbers: |
0220100048 |
First Posted: | April 30, 2012 Key Record Dates |
Results First Posted: | May 11, 2017 |
Last Update Posted: | May 11, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
hypovolemic or septic |
Critical Illness Disease Attributes Pathologic Processes Ascorbic Acid Antioxidants Molecular Mechanisms of Pharmacological Action |
Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Nutrients Growth Substances |