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

NCT02130388 | Terminated DMC

• 1 other identifier: 2013H0127
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Renal Insufficiency

OTHER

Based on creatinine clearance

Dietary Supplement: Zinc

Renal Sufficiency

OTHER

Based on creatinine clearance

Dietary Supplement: Zinc

Interventions

Zinc DIETARY_SUPPLEMENT

Renal Insufficiency; Renal Sufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

OSU Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Sepsis

Interventions

Zinc

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Beth Besecker, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 5, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2019
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

US (1)