High Dose Vitamin C in the Critically Ill Patient (VitC)
This study has been terminated.
(PI's add. responsibilities and time commitment prevent him from completing trial)
Sponsor:
Rutgers, The State University of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01587963
First received: April 26, 2012
Last updated: March 31, 2017
Last verified: March 2017
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Purpose
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 Intervention Model: Parallel Assignment Masking: Participant, Care Provider, 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:
Further study details as provided by Rutgers, The State University of New Jersey:
Primary Outcome Measures:
- 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.
| Enrollment: | 11 |
| Study Start Date: | February 2013 |
| Study Completion Date: | April 2015 |
| Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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.
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587963
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587963
Locations
| United States, New Jersey | |
| Robert Wood Johnson University Hospital | |
| New Brunswick, New Jersey, United States, 08901 | |
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
| Principal Investigator: | Vicente Gracias, MD | RWJMS |
More Information
| Responsible Party: | Rutgers, The State University of New Jersey |
| ClinicalTrials.gov Identifier: | NCT01587963 History of Changes |
| Other Study ID Numbers: |
0220100048 |
| Study First Received: | April 26, 2012 |
| Results First Received: | October 7, 2016 |
| Last Updated: | March 31, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Rutgers, The State University of New Jersey:
|
hypovolemic or septic |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes Vitamins Ascorbic Acid Micronutrients |
Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 25, 2017