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High Dose Vitamin C in the Critically Ill Patient (VitC)

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status and phase

Terminated
Phase 2

Conditions

Shock

Treatments

Other: Ringers Lactate or Normal Saline
Drug: Ascorbic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01587963
0220100048

Details and patient eligibility

About

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

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

11 participants in 2 patient groups, including a placebo group

Ascorbic Acid
Active Comparator group
Description:
Ascorbic Acid
Treatment:
Drug: Ascorbic Acid
Ringers Lactate or Normal Saline
Placebo Comparator group
Description:
Ringers Lactate or Normal Saline
Treatment:
Other: Ringers Lactate or Normal Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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