The Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/3/2017 |
| Start Date: | May 2014 |
| End Date: | August 2018 |
| Contact: | Beth Besecker, MD |
| Email: | beth.besecker@osumc.edu |
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.
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.
Previous research has shown that zinc supplementation reduces the length and severity of some
types of medical infections (examples include the cold virus and diarrhea). Because zinc has
been shown to improve the immune system's function, some doctors provide mineral supplements
such as zinc to their patients in the Intensive Care Unit. However, there are no studies to
show how effective zinc is or that have evaluated what dose(s) of zinc are safe in patients
with severe sepsis/septic shock. Nor have studies examined if tolerable doses for septic
patients can improve how the immune system functions.
If zinc is shown to improve how the immune system functions during sepsis, it could be used
in the future as part of the treatment regimen for patients with sepsis.
types of medical infections (examples include the cold virus and diarrhea). Because zinc has
been shown to improve the immune system's function, some doctors provide mineral supplements
such as zinc to their patients in the Intensive Care Unit. However, there are no studies to
show how effective zinc is or that have evaluated what dose(s) of zinc are safe in patients
with severe sepsis/septic shock. Nor have studies examined if tolerable doses for septic
patients can improve how the immune system functions.
If zinc is shown to improve how the immune system functions during sepsis, it could be used
in the future as part of the treatment regimen for patients with sepsis.
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.
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