Back to resultsHigh Dose Vitamin C in the Critically Ill Patient (VitC)
Primary Purpose
Shock
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ascorbic Acid
Ringers Lactate or Normal Saline
Sponsored by
About this trial
This is an interventional prevention trial for Shock focused on measuring hypovolemic or septic
Eligibility 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)
Sites / Locations
- Robert Wood Johnson University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ascorbic Acid
Ringers Lactate or Normal Saline
Arm Description
Ascorbic Acid
Ringers Lactate or Normal Saline
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01587963
First Posted
April 26, 2012
Last Updated
March 31, 2017
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT01587963
Brief Title
High Dose Vitamin C in the Critically Ill Patient
Acronym
VitC
Official Title
The Efficacy of High Dose Vitamin C in the Critically Ill Patient Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
PI's add. responsibilities and time commitment prevent him from completing trial
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock
Keywords
hypovolemic or septic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ascorbic Acid
Arm Type
Active Comparator
Arm Description
Ascorbic Acid
Arm Title
Ringers Lactate or Normal Saline
Arm Type
Placebo Comparator
Arm Description
Ringers Lactate or Normal Saline
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Vit C
Intervention Description
66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams
Intervention Type
Other
Intervention Name(s)
Ringers Lactate or Normal Saline
Other Intervention Name(s)
Placebo
Intervention Description
Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.
Primary Outcome Measure Information:
Title
Efficacy of High Dose Vitamin C Therapy in Shock Patients
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Gracias, MD
Organizational Affiliation
RWJMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High Dose Vitamin C in the Critically Ill Patient
We'll reach out to this number within 24 hrs