High Dose Vitamin C in the Critically Ill Patient

Phase 2

Terminated

• Conditions: Shock
• Interventions: Other: Ringers Lactate or Normal Saline; Drug: Ascorbic Acid

• Registration Number: NCT01587963
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Study Start: 2013-02
• Primary Completion: 2014-02
• Study Completion: 2015-04
• Results First Submitted: 2016-10-07
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Results First Posted: 2017-05-11
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringers Lactate or Normal Saline	Ringers Lactate or Normal Saline	Ringers Lactate or Normal Saline
Ascorbic Acid	Ascorbic Acid	Ascorbic Acid

Primary Outcome Measures

Name	Time	Method
Efficacy of High Dose Vitamin C Therapy in Shock Patients	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.

Trial Locations

Locations (1)

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States