Severe sepsis with septic shock. Severe sepsis with septic shock
Conditions
Interventions
Intervention 1: Intervention group: Routine treatment plus oral melatonin 10 mg manufactured by Jalinous Pharmaceutical Factory, 2 tablets orally every night for 5 days. Intervention 2: Control group:
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years and older Diagnosed with sepsis or septic shock within 24 hours or more of ICU admission Patients who themselves or their legal guardian sign the informed consent form Able to swallow or have an NG tube
Exclusion criteria
Exclusion criteria: Patients who have a history of allergy and sensitivity to melatonin or any of its components Pregnant and lactating patients patients with End-stage renal disease requiring hemodialysis
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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
Outcome results
None listed