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

The Ohio State University

Status

Terminated

Conditions

Sepsis

Treatments

Dietary Supplement: Zinc

Study type

Interventional

Funder types

Other

Identifiers

NCT02130388

2013H0127

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.