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The Effect of Zinc in the Treatment of Sepsis and Septic Shock

Evaluation of the Effect of Zinc on Clinical Outcomes in Adult Patients with Sepsis and Septic Shock: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210519051348N2
Enrollment
60
Registered
2025-02-03
Start date
2025-02-19
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis and Septic Shock. Severe sepsis with septic shock

Interventions

Intervention 1: Intervention group: Routine treatment plus 50 mg oral zinc sulfate (manufactured by ALHAVIPharmaceutical Factory), administered once daily orally during the ICU stay. Intervention 2: C

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1-Age 18 years and older 2-Those diagnosed with sepsis or septic shock, based on clinical and laboratory methods, within 24 hours or more of being admitted to the intensive care unit 3-Patients who themselves or their legal guardian sign the informed consent form 4-Patients who have the ability to swallow or have an NG tube inserted.

Exclusion criteria

Exclusion criteria: 1. Patients with an allergy to zinc or any of its components.2. Pregnancy and breastfeeding.3. Individuals whose medications interact with zinc.4. Individuals in the final stage of kidney failure undergoing hemodialysis.5. Individuals who were taking zinc prior to entering the study.6. Individuals who have previously participated in the study.7. Patients receiving Adamal and Tracutil.8. Patients with Wilson's disease.

Design outcomes

Primary

MeasureTime frame
Event of Death. Timepoint: From ICU admission to discharge, on a daily basis. Method of measurement: By clinical observation.;Duration of hospitalization. Timepoint: From hospital admission to discharge, on a daily basis. Method of measurement: By clinical observation.;Duration of ICU stay. Timepoint: From ICU admission to discharge from ICU , on a daily basis. Method of measurement: By clinical observation.;Vasopressor Requirement. Timepoint: During ICU stay, based on the days vasopressors are received. Method of measurement: Clinical observation and medical records.

Secondary

MeasureTime frame
Acute Kidney Injury Incidence. Timepoint: In the beginning and every 48 hours thereafter. Method of measurement: Clinical observation and laboratory tests.;Need for Hemodialysis. Timepoint: In the beginning and every 48 hours thereafter. Method of measurement: Clinical observation and hospital records.;APACHE II Score. Timepoint: At the beginning of treatment. Method of measurement: Clinical assessment and laboratory data.;SOFA Score. Timepoint: On days 1, 3, 5, 7, 10, and so on, throughout the ICU stay. Method of measurement: Clinical assessment and laboratory data.;Duration of Mechanical Ventilation. Timepoint: During ICU stay, based on the days ventilator support is provided. Method of measurement: Clinical observation and medical records.;Serum Procalcitonin Level. Timepoint: At the beginning and on day 5 of treatment. Method of measurement: Blood test.;C-Reactive protein. Timepoint: At the beginning and on day 5 of treatment. Method of measurement: Blood test.;Body temperature. Timepoint: In the beginning and every 48 hours thereafter. Method of measurement: Thermometer.;White Blood Cell Count. Timepoint: In the beginning and every 48 hours thereafter. Method of measurement: Blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLaleh Mahmoudi

Shiraz University of Medical Sciences

mahmoudi_l@sums.ac.ir+98 71 3242 4127

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026