Ascorbic Acid (Vitamin C) Infusion in Human Sepsis

NCT01434121 | Completed Phase 1 Results DMC

• 1 other identifier: HM12903
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The major goal of this project is to determine whether intravenously infused ascorbic acid is safe for use as a viable therapeutic strategy in adult humans with sepsis.

Conditions

Sepsis; Septic Shock; Hypotension; Acute Lung Injury

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Experienced Ascorbic Acid Infusion Related Arterial Hypotension, Vomiting, or Tachycardia in Septic Patients

  There were no instances of arterial hypotension, vomiting, or tachycardia within the study population related to the study drug

  during time of infusion- 96 hours from time of enrollment

Secondary Outcomes (6)

• Intensive Care Unit Length of Stay

  subject will be followed until discharged from the ICU, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first

• Duration of Mechanical Ventilation

  subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 28 days from time of enrollment, whichever is first

• Ventilator-free Days

  subject will be followed until discharged from the hospital, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first

• Length of Time on Vasopressor Medication

  during time of infusion - 96 hours from time of enrollment

• Multiple Organ Dysfunction Score

  during time of infusion - 96 hours from time of enrollment

Study Arms (3)

High Dose Ascorbic Acid

ACTIVE COMPARATOR

Subject receives a high dose of infused Vitamin C

Drug: Ascorbic Acid

Low Dose Ascorbic Acid

ACTIVE COMPARATOR

Subject receives a low dose of infused Vitamin C

Drug: Ascorbic Acid

Placebo

PLACEBO COMPARATOR

Subject receives an infusion of saline

Drug: Placebo

Interventions

Ascorbic Acid DRUG

The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo

Also known as: Vitamin C

High Dose Ascorbic Acid; Low Dose Ascorbic Acid

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• systemic inflammatory response: fever (38°C or greater) or hypothermia (36°C or lower), tachypnea (20 breaths/min) or need for mechanical ventilation for an acute process, tachycardia (rate 90/min or more), white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3 or more than 10% band forms.
• Presumed or Known Site of Infection: Purulent sputum, chest radiograph with new infiltrate, spillage of bowel contents, radiographic or physical examination evidence of an infected collection, white blood cells in a normally sterile body fluid, positive blood culture, evidence of infected mechanical hardware by physical, radiographic, or ultrasonographic evidence.
• Evidence of Dysfunction of One or More End Organs: cardiovascular dysfunction: mean arterial pressure 60 mm Hg or less, the need for vasopressors to maintain this pressure in the presence of adequate intravascular volume (central venous pressure 12 mmHg); respiratory failure: (arterial PO2-to-FiO2 ratio of less than 250 or less than 200 in the presence of pneumonia; renal dysfunction: Urine output ≤ 0.5 ml/kg/hr for 2 hours in the presence of adequate intravascular volume or doubling of the serum creatinine; hematologic dysfunction: thrombocytopenia ≤ 80,000 platelets/mm3 or 50% decrease from baseline during the acute illness; Unexplained metabolic acidosis: arterial pH ≤ 7.3 and a plasma lactate level higher than 2.5. Hepatic Dysfunction: Acute Serum transaminase elevation greater than five times normal.
• Informed Consent: Ability to obtain informed consent within 48 hours.

You may not qualify if:

• Demographic Characteristics: Children (age \< 18 years), pregnant women, prisoners, and other wards of the state are excluded from participation in this study.
• Informed Consent: Inability to obtain informed consent within 48 hours.
• Cognitive Impairment: In the absence of family or next of kin, if the investigators feel the patient is cognitively impaired, and unable to provide informed consent, the patient will not be accessed to the study.
• Non-English Speaking Patients: Patients who are non english speaking will not be accessed to this study.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• Fowler AA 3rd, Syed AA, Knowlson S, Sculthorpe R, Farthing D, DeWilde C, Farthing CA, Larus TL, Martin E, Brophy DF, Gupta S; Medical Respiratory Intensive Care Unit Nursing; Fisher BJ, Natarajan R. Phase I safety trial of intravenous ascorbic acid in patients with severe sepsis. J Transl Med. 2014 Jan 31;12:32. doi: 10.1186/1479-5876-12-32.

  PMID: 24484547 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic; Hypotension; Acute Lung Injury

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Vascular Diseases; Cardiovascular Diseases; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Alpha A. Fowler, III, MD
• Organization: Virginia Commonweath University

afowler@mcvh-vcu.edu

804-628-5710

Study Officials

• Alpha Fowler, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: September 14, 2011
• Study Start: May 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 1, 2018
• Results First Posted: July 1, 2014

Record last verified: 2018-01

Locations

US (1)