High Dose Vitamin C in the Critically Ill Patient

Shock Clinical Trial

— VitC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01587963
• Other study ID #: 0220100048
• Status: Terminated
• Phase: Phase 2
• First received: April 26, 2012
• Last updated: May 20, 2015
• Start date: February 2013
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Shock

Intervention

Drug:
• Ascorbic Acid
66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams

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.

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes