Back to resultsThe Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis
Primary Purpose
Sepsis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zinc
Sponsored by
About this trial
This is an interventional other trial for 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.
Sites / Locations
- OSU Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Renal Insufficiency
Renal Sufficiency
Arm Description
Based on creatinine clearance
Based on creatinine clearance
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02130388
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow Recruitment and funds no longer available.
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renal Insufficiency
Arm Type
Other
Arm Description
Based on creatinine clearance
Arm Title
Renal Sufficiency
Arm Type
Other
Arm Description
Based on creatinine clearance
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Primary Outcome Measure Information:
Title
Toxicity will be monitored clinically for symptoms such as new vomiting or diarrhea and by serum zinc and copper levels.
Description
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.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Besecker, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSU Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis
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