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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01587963
First received: April 26, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Shock
Drug: Ascorbic Acid
Other: Ringers Lactate or Normal Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of High Dose Vitamin C in the Critically Ill Patient Population

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Efficacy of high dose vitamin C therapy in shock patients [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ascorbic Acid Drug: Ascorbic Acid
66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams
Placebo Comparator: Ringers Lactate or Normal Saline 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587963

Contacts
Contact: Susette Coyle, RN 732-235-8143 coylesu@rwjms.rutgers.edu
Contact: Marie Macor, RN 732-235-8143 macorma@rwjms.rutgers.edu

Locations
United States, New Jersey
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Vicente Gracias, MD         
Principal Investigator: Vicente Gracias, MD         
Sub-Investigator: Meredith Tinti, MD         
Sub-Investigator: Adam Shiroff, MD         
Sub-Investigator: Hesham Ahmed, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Vicente Gracias, MD RWJMS
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01587963     History of Changes
Other Study ID Numbers: 0220100048
Study First Received: April 26, 2012
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
hypovolemic or septic

Additional relevant MeSH terms:
Ascorbic Acid
Critical Illness
Shock
Disease Attributes
Pathologic Processes
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 11, 2014