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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 is a Phase 2 study that was terminated before completion, run by Christiana Care Health Services. The registered enrollment target is 24 participants.
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.
Interventions
- OTHER Normal Saline
- DRUG Ascorbic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2017-11-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02734147
The ClinicalTrials.gov registry entry for NCT02734147 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Christiana Care Health Services, which has 82 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT02734147 reports 0 study locations.
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.
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