SepsisNCT02130388

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

A study testing Zinc in people with Sepsis, run by Ohio State University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis
What is being tested?: Zinc
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: May 2014to Mar 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

OSU Medical Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Read the 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
Being tested: Zinc
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZincDietary supplement

Study groups in NCT02130388
Study group	Role	What they receive
Renal Insufficiency	Other	Based on creatinine clearance Receives: Dietary Supplement: Zinc
Renal Sufficiency	Other	Based on creatinine clearance Receives: Dietary Supplement: Zinc

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Mar 2019

First posted5 May 2014 (estimated)
Study startMay 2014
Primary completionOct 2017
Study completionMar 2019

Why it stopped: Slow Recruitment and funds no longer available.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02130388
Sponsor's protocol ID: 2013H0127
Status last verified: Jul 2021
First submitted: 29 Apr 2014
Last updated: 22 Jul 2021
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Zinc Supplementation on Innate Immunity and Patient Safety in Sepsis
ClinicalTrials.gov ID: NCT02130388
Acronym / sponsor ID: 2013H0127
Conditions: Sepsis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow Recruitment and funds no longer available.
Enrolment: 10 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: May 2014
Primary completion: Oct 2017 (actual)
Study completion: Mar 2019 (actual)
First posted: 5 May 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Renal Insufficiency	Other	Dietary Supplement: ZincBased on creatinine clearance
Renal Sufficiency	Other	Dietary Supplement: ZincBased on creatinine clearance

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zinc	Dietary supplement	Renal Insufficiency, Renal Sufficiency

Primary outcome

Toxicity will be monitored clinically for symptoms such as new vomiting or diarrhea and by serum zinc and copper levels.
Time frame: 10 days
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.

Results and safety

The study was stopped early (reason given: Slow Recruitment and funds no longer available.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Beth Besecker, MD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Zinc in people with Sepsis, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow Recruitment and funds no longer available.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity will be monitored clinically for symptoms such as new vomiting or diarrhea and by serum zinc and copper levels. (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02130388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.