High Dose Vitamin C in the Critically Ill Patient

NCT01587963 | Terminated Phase 2 Results DMC

• 1 other identifier: 0220100048
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shock

Keywords

hypovolemic or septic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ascorbic Acid

ACTIVE COMPARATOR

Ascorbic Acid

Drug: Ascorbic Acid

Ringers Lactate or Normal Saline

PLACEBO COMPARATOR

Ringers Lactate or Normal Saline

Other: Ringers Lactate or Normal Saline

Interventions

Ascorbic Acid DRUG

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

Also known as: Vit C

Ascorbic Acid

Ringers Lactate or Normal Saline OTHER

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

Also known as: Placebo

Ringers Lactate or Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Shock; Hypovolemia

Interventions

Ascorbic Acid; Ringer's Lactate; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Early termination leading to small number of subjects analyzed

Results Point of Contact

• Title: Vincente Gracias
• Organization: Rutgers RWJMS

graciavh@rwjms.rutgers.edu

732-235-7920

Study Officials

• Vicente Gracias, MD

  RWJMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 11, 2017
• Results First Posted: May 11, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)