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NCT02734147 · ClinicalTrials.gov registry record · Phase 2

High Dose Intravenous Ascorbic Acid in Severe Sepsis

A Phase 2 study, sponsored by Christiana Care Health Services.

Terminated
Registry status
Phase 2
Development phase
24
Enrollment target

NCT02734147: Clinical Trial Phase 2 study, sponsored by Christiana Care Health Services.

NCT02734147 is a Phase 2 study that was terminated before completion, run by Christiana Care Health Services. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02734147, a Phase 2 study, was terminated before completion, sponsored by Christiana Care Health Services.

TERMINATED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study Summary

Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult, and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence continues to rise, making sepsis the most expensive inpatient disease. 1. Recent research has described the therapeutic benefits associated with ascorbic acid treatment for sepsis. 2. Researchers objectives are to perform a randomized-controlled clinical trial investigating the ability of ascorbic acid(vitamin C) administration to decrease organ dysfunction in severe sepsis. The widespread occurrence of microvascular dysfunction in sepsis leading to tissue hypoxia, mitochondrial dysfunction, and adenosine triphosphate (ATP) depletion, gives rise to organ failure. 3. Patients with organ failure and sepsis (severe sepsis) are at a higher risk of death than patients with organ failure alone. Critically ill patients may have an increased requirement for ascorbic acid in sepsis and these patients frequently have levels below normal. Ascorbic acid administration, has been shown to correlate inversely with organ failure (human literature) and directly with survival (animal studies). 4,5 Intravenous ascorbic acid therapy decreases organ failure by providing a protective effect on several microvascular functions including improving capillary blood flow, decreasing microvascular permeability, and improving arteriolar responsiveness to vasoconstrictors. Defining the utility of novel agents to augment researchers care for severe sepsis is an important task as investigators continue the institutional focus on sepsis care.

Primary Outcome

Sequential Organ Failure Assessment (SOFA) Score included the degree of dysfunction of six organ systems (Respiratory, Cardiovascular, Liver, Renal, Coagulation, Neurologic. A modification of the SOFA includes the exclusion of the Liver function. Total score is reported, minimum score = 0 maximum score = 20. Higher scores indicate greater degree of dysfunction.

Interventions

  • OTHER Normal Saline
  • DRUG Ascorbic Acid

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-04-01
Est. Completion 2017-11-23
Phase Phase 2
Christiana Care Health Services

82 total trials

Why NCT02734147 stopped before completion

NCT02734147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.

NCT02734147 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02734147 about?

NCT02734147 is a clinical study titled "High Dose Intravenous Ascorbic Acid in Severe Sepsis". Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult, and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence continues to rise, making ...

What is the current status of trial NCT02734147?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2016-04-01. Estimated completion is 2017-11-23.

What interventions are being tested in trial NCT02734147?

The interventions under investigation include: Normal Saline (OTHER), Ascorbic Acid (DRUG).

Who is sponsoring clinical trial NCT02734147?

This trial is sponsored by Christiana Care Health Services, which has 82 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02734147's enrollment target sits among peer trials

24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02734147, the US trial registry maintained by the National Library of Medicine. NCT02734147 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.