Effaect of Statin on Sepsis and organ dysfunction

Comparison of the effect of statin and placebo on the development of sepsis and organ dysfunction in ICU patients.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180713040452N1

Enrollment

Registered

2019-05-02

Start date

2019-04-21

Completion date

Unknown

Last updated

2019-05-21

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

Conditions

sepsis. Other specified sepsis

Interventions

Intervention 1: Intervention group: Patients in this group receive Atorvastatin 40 mg oral tablet, produced by the Abidi Company, daily for one month. Intervention 2: Control group: Patients in this g

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years old Patient with sepsis in the context of pneumonia and urinary tract infections.

Exclusion criteria

Exclusion criteria: The patient has previously been treated with statin The patient was previously afflicted with organ failure Patients in whom a history of statin use in the past is not available

Design outcomes

Primary

Measure	Time frame
Erythrocyte Sedimentation Rate. Timepoint: Measurement on days 0, 3, 7, 14. Method of measurement: This variable is measured by the laboratory.;C-Reactive Protein. Timepoint: Measurement on days 0, 3, 7, 14. Method of measurement: This variable is measured by the laboratory.;APACHE II score. Timepoint: Measurement on days 0, 3, 7, 14. Method of measurement: The point score is calculated from a patient's age and 12 routine physiological measurements: 1) PaCO2 or PaO2 (depending on FiO2) 2)Temperature 3)Mean arterial pressure 4)pH arterial 5)Heart rate 6)Respiratory rate 7)Sodium (serum) 8) Potassium (serum) 9)Creatinine 10)Hematocrit 11)White blood cell count 12)Glasgow Coma Scale.;Nervous system failure. Timepoint: daily. Method of measurement: Based on Glasgow Coma Scale.;Renal Failure. Timepoint: daily. Method of measurement: 1) Increased creatinine by more than 0.5 units in 72 hours; 2) Increased creatinine by more than 1.5 units during treatment; 3) Reduced glomerular filtration rate by more than 20 percent during treatment.;Hepatic failure. Timepoint: daily. Method of measurement: 1) Increase in alanine transaminase and aspartate transaminase during treatment, 2) Increase of the international normalize ratio and prothrombin time and partial thromboplastin time during treatment.;Pulmonary failure. Timepoint: daily. Method of measurement: 1) The ratio of FIO2 to PaO2 is less than 2 to 250. 2) Increased need for ventilation support.	—

Measure

Time frame

Erythrocyte Sedimentation Rate. Timepoint: Measurement on days 0, 3, 7, 14. Method of measurement: This variable is measured by the laboratory.;C-Reactive Protein. Timepoint: Measurement on days 0, 3, 7, 14. Method of measurement: This variable is measured by the laboratory.;APACHE II score. Timepoint: Measurement on days 0, 3, 7, 14. Method of measurement: The point score is calculated from a patient's age and 12 routine physiological measurements: 1) PaCO2 or PaO2 (depending on FiO2) 2)Temperature 3)Mean arterial pressure 4)pH arterial 5)Heart rate 6)Respiratory rate 7)Sodium (serum) 8) Potassium (serum) 9)Creatinine 10)Hematocrit 11)White blood cell count 12)Glasgow Coma Scale.;Nervous system failure. Timepoint: daily. Method of measurement: Based on Glasgow Coma Scale.;Renal Failure. Timepoint: daily. Method of measurement: 1) Increased creatinine by more than 0.5 units in 72 hours; 2) Increased creatinine by more than 1.5 units during treatment; 3) Reduced glomerular filtration rate by more than 20 percent during treatment.;Hepatic failure. Timepoint: daily. Method of measurement: 1) Increase in alanine transaminase and aspartate transaminase during treatment, 2) Increase of the international normalize ratio and prothrombin time and partial thromboplastin time during treatment.;Pulmonary failure. Timepoint: daily. Method of measurement: 1) The ratio of FIO2 to PaO2 is less than 2 to 250. 2) Increased need for ventilation support.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSahand Astaneh

Arak University of Medical Sciences

s.astaneh@arakmu.ac.ir+98 86 3422 4253

Outcome results

None listed

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