SEPSIS. Severe sepsis with septic shock
Conditions
Interventions
Intervention group: 10 mg melatonin tablets from Norm Life company are taken every 8 hour for 7 days..
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients 18 to 85 years old Based on diagnostic criteria (increase of at least 2 SOFA scores compared to baseline in patients suspected of infection), sepsis should be considered for the patient. The patient or the patient's companion must have an informed and freely written consent form to participate in the study.
Exclusion criteria
Exclusion criteria: Severe heart failure Severe liver dysfunction (liver enzyme more than three times the normal limit) Pregnancy and lactation Dialysis patients History of hypersensitivity or any contraindications to melatonin Previous history of cardiovascular attacks Uncontrolled diabetes (HbA1C>8.5)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigating the effects of high dose melatonin in the prevention of heart damage secondary to sepsis. Timepoint: The beginning of the study (before intervention) and 7 days after the start of melatonin consumption. Method of measurement: Laboratory kit for measuring NT-PROBNP blood samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigating the effects of high doses of melatonin on Troponin I levels in the prevention of heart damage secondary to sepsis. Timepoint: The beginning of the study (before intervention) and 7 days after the start of melatonin consumption. Method of measurement: Laboratory kit for measuring Troponin I blood samples.;Investigating the effects of high doses of melatonin on the duration of mechanical ventilation. Timepoint: The beginning of the study (before intervention) and 7 days after the start of melatonin consumption. Method of measurement: Clinical observation.;Investigating the effects of high doses of melatonin on the duration of hospitalization in the intensive care unit. Timepoint: The beginning of the study (before the start of the intervention) until the time of discharge from the ICU. Method of measurement: Clinical observation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahdi Emami
Tehran University of Medical Sciences
Outcome results
None listed