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

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.

Study Overview

• Status: Terminated
• Conditions: Sepsis
• Intervention / Treatment: Dietary supplement: Zinc

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • OSU Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Renal Insufficiency; Based on creatinine clearance	Dietary supplement: Zinc
Other: Renal Sufficiency; Based on creatinine clearance	Dietary supplement: Zinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity will be monitored clinically for symptoms such as new vomiting or diarrhea and by serum zinc and copper levels.	This study consists of receiving a dose of zinc once daily while in the ICU for up to 7 days, up to four timed blood draws over the first 10 days of your hospitalization (if you remain in the hospital that long), and collecting some immune cells from your blood +/- lungs. We will review your medical chart at the time of the blood draws and again when you are getting ready for discharge.	10 days

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Beth Besecker, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2013H0127