Vitamin C and Septic Shock

NCT ID: NCT03338569

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-20
• Study Completion Date: 2020-08-10

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.

Detailed Description

This is a multi-site, randomized, double-blind, placebo-controlled trial comparing a regimen of moderate-dose (6000 mg per day) Vitamin C supplementation versus placebo for the treatment of patients presenting to the ICU with septic shock. Both groups will continue to receive all other standard of care measures for septic shock as clinically indicated. Groups will be enrolled and receive study drug/placebo for 4 days (96 hours) or until 24 hours post-last pressor dose, whichever is sooner.

Conditions

Septic Shock; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo designed to mimic intervention

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo designed to mimic intervention

Intervention

6000 mg per day Vitamin C supplement

Group Type: ACTIVE_COMPARATOR

Vitamin C

Intervention Type: DRUG

Continuous infusion of vitamin C

Interventions

Vitamin C

Continuous infusion of vitamin C

Intervention Type: DRUG

Placebo

Placebo designed to mimic intervention

Intervention Type: DRUG

Other Intervention Names

ascorbic acid

Eligibility Criteria

Inclusion Criteria

• • 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.

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34982738 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00000625

Identifier Type: -

Identifier Source: org_study_id