The Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis (NCT02130388) | Clinical Trial Compass
TerminatedNot Applicable
The Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis
Stopped: Slow Recruitment and funds no longer available.
United States10 participantsStarted 2014-05
Plain-language summary
Sepsis is the body's response to a life-threatening infection. This study will determine if zinc supplementation is safe to use in patients with severe sepsis or septic shock. This study will also gather preliminary information to evaluate the impact that zinc has on the immune system (the body's defense system against infection) and whether zinc can help monocytes and macrophages (specific types of cells that remove infections from the body) work more effectively.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Admitted to an Ohio State University Medical Center medical Intensive Care Unit
* ≥ 18 years
* Have consensus criteria for severe sepsis (two of four systemic inflammatory response syndrome \[SIRS\] signs \[tachycardia, tachypnea, fever or hypothermia, leukocytosis or leukopenia\]) and a known or suspected infection resulting in an organ failure (i.e. respiratory failure, renal failure, etc.)
* Patient must consent to enrollment within 36 hours of a new episode of sepsis and be able to receive supplementation within 12 hours of enrollment but not to exceed 36 hours since sepsis onset to be eligible.
Exclusion Criteria:
* Consent not available or declined,
* Prisoner, Women who are pregnant or lactating
* Chemotherapy within past 4 weeks or Absolute Neutrophil Count\<500
* AIDS defining illness or Cluster of Differentiation 4 \< 200
* Acute Pancreatitis or amylase/lipase \> 2x normal
* Small Bowel Obstruction or GI condition preventing enteral route of feeding
* C.difficile colitis or active diarrhea
* Active vomiting or current use of Total Parenteral Nutrition within past 30 days
* Predicted ICU length of stay \< 72 hours or moribund
* End Stage Renal Disease on chronic intermittent dialysis
* Previously enrolled in this zinc supplementation study or currently enrolled in another nutritional supplementation trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Toxicity will be monitored clinically for symptoms such as new vomiting or diarrhea and by serum zinc and copper levels.