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

NCT ID: NCT02130388

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-03-31

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.

Conditions

Sepsis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Renal Insufficiency

Based on creatinine clearance

Group Type: OTHER

Zinc

Intervention Type: DIETARY_SUPPLEMENT

Renal Sufficiency

Based on creatinine clearance

Group Type: OTHER

Zinc

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Zinc

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Beth Y Besecker, MD

Assistant Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beth Besecker, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

OSU Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2013H0127

Identifier Type: -

Identifier Source: org_study_id