High Dose Vitamin C in the Critically Ill Patient

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

Detailed Description
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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.

Official Title
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The Efficacy of High Dose Vitamin C in the Critically Ill Patient Population

Conditions
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Shock

Intervention / Treatment
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* Drug: Ascorbic Acid
* Other: Ringers Lactate or Normal Saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ascorbic Acid<br>Ascorbic Acid | Drug: Ascorbic Acid<br>* 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams<br>* Other names: Vit C;|
| Placebo Comparator: Ringers Lactate or Normal Saline<br>Ringers Lactate or Normal Saline | Other: Ringers Lactate or Normal Saline<br>* Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypovolemic or septic