High Dose Vitamin C in the Critically Ill Patient (VitC)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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.

Eligibility Criteria

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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)

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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