High Dose Vitamin C in the Critically Ill Patient

NCT ID: NCT01587963

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-04-30

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.

Conditions

Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Ascorbic Acid

Ascorbic Acid

Group Type: ACTIVE_COMPARATOR

Ascorbic Acid

Intervention Type: DRUG

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

Ringers Lactate or Normal Saline

Ringers Lactate or Normal Saline

Group Type: PLACEBO_COMPARATOR

Ringers Lactate or Normal Saline

Intervention Type: OTHER

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

Interventions

Ascorbic Acid

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Vit C; Placebo

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vicente Gracias, MD

Role: PRINCIPAL_INVESTIGATOR

RWJMS

Locations

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

0220100048

Identifier Type: -

Identifier Source: org_study_id