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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
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Brief Summary:
The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.

Condition or disease Intervention/treatment Phase
Shock Drug: Ascorbic Acid Other: Ringers Lactate or Normal Saline Phase 2

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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Vitamin C
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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, 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)

Information from the National Library of Medicine

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


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

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01587963     History of Changes
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

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