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High-dose Intravenous Vitamin C in Patients With Septic Shock

NCT04796636 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-04

No results posted yet for this study

Summary

Despite promising observational and phase 1 data, the therapeutic potential of vitamin C for the management of septic shock has not borne out in recent large multi-centre randomized controlled trials. There is biological plausibility for benefit with intravenous vitamin C, and the investigators hypothesize that the doses used in these trials were insufficient to demonstrate an effect. High-dose vitamin C has been trialed in patients with cancer and burns and proven to be safe. The investigators have recently demonstrated a dramatic benefit of high-dose intravenous vitamin C in reversing organ dysfunction in a large mammalian model of sepsis. The proposed prospective interventional study will be the first to administer high-dose intravenous vitamin C in critically ill patients with sepsis. The objectives of this study will be to determine whether high-dose intravenous vitamin C (i) reduces vasopressor requirement in critically ill patients with septic shock (ii) reverses organ dysfunction and (iii) is well tolerated.

Conditions

  • Sepsis, Severe
  • Septic Shock

Interventions

DRUG

Sodium Ascorbate

As previously described

Sponsors & Collaborators

  • Monash Medical Centre

    collaborator OTHER

  • The Florey Institute of Neuroscience and Mental Health

    collaborator OTHER

  • University of Melbourne

    collaborator OTHER

  • Melbourne Health

    lead OTHER

Principal Investigators

  • Mark P Plummer, PhD · Melbourne Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2023-09-22
Completion
2023-12-22

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796636 on ClinicalTrials.gov