The Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis

Stopped early · Not applicable

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT02130388

Run by

Ohio State University

People needed

10

Starts

2014-05-01

Expected to finish

2019-03-01

Last updated by the study team

2021-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• OSU Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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