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NCT01162109 · ClinicalTrials.gov registry record · Phase 1
Zinc Therapy in Critical Illness
A Phase 1 study of Severe Sepsis, sponsored by University of Vermont.
- Active
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT01162109 is a Phase 1 study of Severe Sepsis that is active but no longer recruiting, run by University of Vermont. The registered enrollment target is 55 participants, below the 6,205-participant average among 9 other Severe Sepsis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01162109, a Phase 1 study of Severe Sepsis, is active but no longer recruiting, sponsored by University of Vermont.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
Sepsis is a clinical syndrome often caused by a bloodstream infection that results in a common set of symptoms termed systemic inflammatory response syndrome (SIRS). Severe sepsis (sepsis with organ failure) is the leading cause of death in critically ill patients in the US. Most patients with severe sepsis need to be treated in the intensive care unit with mechanical ventilation and intravenous antibiotics. Between 30 to 50% of all severe sepsis patients die and quality of life in survivors is substantially reduced. New therapies are needed to improve clinical outcomes in patients with sepsis. A new area of interest in the treatment of critical illness is pharmaconutrition, in which micronutrients (like zinc) are studied and administered to determine if they affect the inflammatory response or immunologic processes in critical illness. The FDA does not regulate micronutrients and does not require rigorous pharmacokinetic (the study of how a drug or nutrient is metabolized in the body) testing so it is not clear how to dose micronutrients in critically ill patients. It is also not clear if critically ill patients would metabolize these micronutrients differently than healthy people and would need different dosing levels. This is true of zinc, the focus of this research study. Zinc is essential for normal immune function, oxidative stress response, and wound healing, and its homeostasis is tightly regulated. Zinc deficiency occurs in \>10% of Americans and leads to loss of innate and adaptive immunity and increased susceptibility to infections. The symptoms of zinc deficiency are similar to many of the symptoms of SIRS and there is strong biologic rationale to suggest that the zinc deficiency seen in nearly all sepsis patients may contribute to the development of sepsis syndrome and to the "immunoparalysis" common in sepsis patients This study has three specific aims, 1) to perform a phase I dose-finding study of intravenous zinc in mechanically ventilated patient
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Zinc sulfate
Study Locations (1)
Vermont
- University of Vermont College of Medicine - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2010-09 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01162109
The ClinicalTrials.gov registry entry for NCT01162109 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,205-participant average among 9 other Severe Sepsis trials with a reported enrollment target (99% lower). The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Severe Sepsis appearing as the primary indexed condition, and to 1 intervention - of which Zinc sulfate is the first listed.
NCT01162109 reports 1 study location spanning 1 distinct geographic area - top geographies include Vermont.
Frequently Asked Questions
What is clinical trial NCT01162109 about?
NCT01162109 is a clinical study titled "Zinc Therapy in Critical Illness". Sepsis is a clinical syndrome often caused by a bloodstream infection that results in a common set of symptoms termed systemic inflammatory response syndrome (SIRS). Severe sepsis (sepsis with organ failure) is the leading cause of death in critically ill patients in the US. Most patients with sever...
What is the current status of trial NCT01162109?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2010-09. Estimated completion is 2025-12.
What conditions does trial NCT01162109 study?
This clinical trial studies the following conditions: Severe Sepsis.
What interventions are being tested in trial NCT01162109?
The interventions under investigation include: Zinc sulfate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01162109?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01162109 being conducted?
This trial has 1 study location across Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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