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NCT03422159 · ClinicalTrials.gov registry record · Phase 2
Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.
A Phase 2 study, sponsored by Community Medical Center, Toms River, NJ.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
NCT03422159 is a Phase 2 study that has completed, run by Community Medical Center, Toms River, NJ. The registered enrollment target is 140 participants.
The verdict
NCT03422159, a Phase 2 study, has completed, sponsored by Community Medical Center, Toms River, NJ.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
Study Summary
This study has been created to compare the addition of intravenous (IV) vitamin C, thiamine, and hydrocortisone to the usual standard of care of sepsis and septic shock. Sepsis is a possibly life-threatening condition in which a patient may have organ dysfunction due to an infection. Septic shock is defined as low blood pressure and organ dysfunction that do not improve after administering IV fluids. Standard of care for sepsis and septic shock include early administration of IV antibiotics, IV fluids, and vasopressors if need be to provide oxygen to vital organs. A large amount of experimental data has shown that vitamin C and corticosteroids decrease the release of inflammatory substances which may lead to organ failure seen in sepsis. Vitamin C and corticosteroids also improve blood flow to vital organs and increase the body's ability to respond well to vasopressor medications used in septic shock. Low blood levels of both thiamine and vitamin C are common in sepsis. The study will be placebo controlled, meaning one group will receive vitamin C, thiamine, and hydrocortisone, and the other will receive an inactive substance ("placebo"). The goal of the study is to compare the effects of receiving vitamin C, thiamine, and hydrocortisone (along with the standard sepsis care) versus placebo and standard sepsis care.
Interventions
- DRUG Thiamine
- DRUG Hydrocortisone
- DRUG Sodium Chloride 0.9%
- DRUG Ascorbic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2019-08-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03422159
The ClinicalTrials.gov registry entry for NCT03422159 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Community Medical Center, Toms River, NJ, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Thiamine is the first listed.
NCT03422159 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03422159 about?
NCT03422159 is a clinical study titled "Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.". This study has been created to compare the addition of intravenous (IV) vitamin C, thiamine, and hydrocortisone to the usual standard of care of sepsis and septic shock. Sepsis is a possibly life-threatening condition in which a patient may have organ dysfunction due to an infection. Septic shock is...
What is the current status of trial NCT03422159?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2018-02-05. Estimated completion is 2019-08-27.
What interventions are being tested in trial NCT03422159?
The interventions under investigation include: Thiamine (DRUG), Hydrocortisone (DRUG), Sodium Chloride 0.9% (DRUG), Ascorbic Acid (DRUG).
Who is sponsoring clinical trial NCT03422159?
This trial is sponsored by Community Medical Center, Toms River, NJ, which has 3 total clinical trials registered on ClinicalTrials.gov.
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