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

• ClinicalTrials.gov Identifier: NCT01587963
• Recruitment Status: Terminated
• First Posted: April 30, 2012
• Results First Posted: May 11, 2017
• Last Update Posted: May 11, 2017
• Sponsor: Rutgers, The State University of New Jersey
• Information provided by (Responsible Party): Rutgers, The State University of New Jersey

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• 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; Ascorbic Acid; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Vitamins; Micronutrients; Nutrients; Growth Substances