Clinical trial NCT02130388: The Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis
Official title: The Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sepsis
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Toxicity will be monitored clinically for symptoms such as new vomiting or diarrhea and by serum zinc and copper levels.
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OSU Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Beth Besecker, MD
role: PRINCIPAL_INVESTIGATOR
References: