Vitamin C and Septic Shock

NCT03338569 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY00000625
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.

Conditions

Septic Shock; Sepsis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With ICU Mortality

  Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).

  28 days

• All Cause Mortality at 28 Days

  Outcome is reported as the number of participants who have expired at 28 days post intervention

  28 days

Secondary Outcomes (10)

• Duration of Vasopressor Therapy

  28 days

• Duration of ICU Stay Post Intervention Administration

  28 days

• Time to Lactate Clearance Post Intervention Administration

  28 days

• Rate of Lactate Clearance Post Intervention Administration

  24, 48, 72, and 96 hours post intervention

• Rate of Procalcitonin Clearance Post Intervention Administration

  4 days

Study Arms (2)

Placebo

SHAM COMPARATOR

Placebo designed to mimic intervention

Drug: Placebo

Intervention

ACTIVE COMPARATOR

6000 mg per day Vitamin C supplement

Drug: Vitamin C

Interventions

Vitamin C DRUG

Continuous infusion of vitamin C

Also known as: ascorbic acid

Intervention

Placebo DRUG

Placebo designed to mimic intervention

Placebo

Eligibility Criteria

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

You may qualify if:

• Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.
• Age ≥ 18 years
• Septic shock as pragmatically defined as:
• o Order for intravenous antimicrobials with either procalcitonin \> 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND
• Hypotension requiring vasopressor therapy, despite fluid resuscitation of at least 30 cc/kg AND
• Lactate \> 2 mmol/L 24 hr prior to enrollment AND
• Presence of sepsis defined as equal to or greater than 2 SIRS criteria and/or acute increase in qSOFA score of 2 points or more.
• SIRS criteria: 1) Temperature greater than 38° or less than 36° Celsius. 2) Heart rate greater than 90 beats per minute. 3) Respiratory rate greater than 20 breaths per minute OR arterial carbon dioxide tension less than 32 mmHg. 4) White blood cell count greater than 12,000 cell/µL, less than 4,000 cells/µL, OR band cells greater than 10% of the total white blood cell population.
• qSOFA: 1 point each is assigned for: 1) systolic blood pressure below 100, 2) respiratory rate greater than 22, and 3) mental status not at baseline.

You may not qualify if:

• Unable to start infusion within 24 hours of septic shock identification
• Currently pregnant or breastfeeding
• Patient to receive comfort measures only
• Cardiac Arrest
• Cardiovascular Surgery patients receiving prophylactic peri-operative antibiotics \< 48 hours post-operation
• Participation in another study involving an investigational product within 30 days of the baseline visit
• Allergy to Vitamin C
• History of nephrolithiasis
• History of G6PD deficiency
• ESRD patients, transplant eligible on dialysis currently taking vitamin C supplementation
• Clinical course that treating clinician decides would preclude safe participation

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Wacker DA, Burton SL, Berger JP, Hegg AJ, Heisdorffer J, Wang Q, Medcraft EJ, Reilkoff RA. Evaluating Vitamin C in Septic Shock: A Randomized Controlled Trial of Vitamin C Monotherapy. Crit Care Med. 2022 May 1;50(5):e458-e467. doi: 10.1097/CCM.0000000000005427. Epub 2022 Jan 5.

  PMID: 34982738 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ronald Reilkoff, MD
• Organization: University of Minnesota

rreilkof@umn.edu

612-624-0999

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 9, 2017
• Study Start: December 20, 2017
• Primary Completion: June 30, 2020
• Study Completion: August 10, 2020
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-07

Locations

US (1)