High Dose Vitamin C in the Critically Ill Patient

Phase 2TerminatedNCT01587963

Rutgers, The State University of New Jersey11 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Shock

Interventions

Ascorbic AcidDRUG

66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams

Ringers Lactate or Normal SalineOTHER

Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Data from ClinicalTrials.gov

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