High Dose Vitamin C in the Critically Ill Patient (Vit C)
This study is not yet open for participant recruitment.
Verified February 2013 by University of Medicine and Dentistry New Jersey
Sponsor:
University of Medicine and Dentistry New Jersey
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01587963
First received: April 26, 2012
Last updated: February 28, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Shock |
Drug: Ascorbic Acid Other: Ringers Lactate or Normal Saline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Efficacy of High Dose Vitamin C in the Critically Ill Patient Population |
Resource links provided by NLM:
Drug Information available for:
Lactic acid
Ascorbic acid
Sodium ascorbate
Ammonium lactate
Ringer's lactate
U.S. FDA Resources
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- Efficacy of high dose vitamin C therapy in shock patients [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Ascorbic Acid |
Drug: Ascorbic Acid
66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams
|
| Placebo Comparator: Ringers Lactate or Normal Saline |
Other: Ringers Lactate or Normal Saline
Fluid resuscitation will be given with NS or LR to acheive a same mean urine output of 0.5cc/kg/hour.
|
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 and over 70.
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587963
Contacts
| Contact: Susette Coyle, RN | 732-235-8143 | coylesu@umdnj.edu |
| Contact: Marie Macor, RN | 732-235-8143 | macorma@umdnj.edu |
Locations
| United States, New Jersey | |
| Robert Wood Johnson University Hospital | Not yet recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: Vicente Gracias, MD | |
| Principal Investigator: Vicente Gracias, MD | |
| Sub-Investigator: Meredith Tinti, MD | |
| Sub-Investigator: Adam Shiroff, MD | |
| Sub-Investigator: Hesham Ahmed, MD | |
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
| Principal Investigator: | Vicente Gracias, MD | RWJMS |
More Information
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT01587963 History of Changes |
| Other Study ID Numbers: | 0220100048 |
| Study First Received: | April 26, 2012 |
| Last Updated: | February 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
hypovolemic or septic |
Additional relevant MeSH terms:
|
Ascorbic Acid Critical Illness Shock Disease Attributes Pathologic Processes Vitamins Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 17, 2013