The aim of this study is evaluating the effect of statin on the development of sepsis and organ dysfunction in patients with sepsis in the ICU.
Design
This prospective double-blind clinical trial will be performed on 36 patients with sepsis hospitalized in ICU. In this study patients will randomly be divided into two groups of 18 participants.
Settings and conduct
This is a prospective, double-blind clinical trial (participants and researchers are not aware of the information gathering and evaluation process). This study is conducted on patients with sepsis in the context of urinary tract infections or respiratory infections admitted to ICU at Vali Asr Hospital in Arak.
Patients will be screened for vital signs, APACHE II Score, ESR and CRP levels, and the state of the tests, and then with regard to the objectives of the plan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years; Sepsis in the context of pneumonia and urinary tract infections.
Non-inclusion 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.
Intervention groups
Patients in the intervention group receive Atorvastatin 40 mg oral tablet, daily for one month.
Patients in the control group are given placebo for one month.
Main outcome variables
The outcome variables include ESR; CRP; APACHE II; blood sugar; GCS; GFR; serum creatinine; AST; ALT; PT; PTT; INR; FIO2 to PaO2 ratio.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180713040452N1
Registration date:2019-05-02, 1398/02/12
Registration timing:registered_while_recruiting
Last update:2019-05-02, 1398/02/12
Update count:0
Registration date
2019-05-02, 1398/02/12
Registrant information
Name
Sahand Astaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3422 4253
Email address
s.astaneh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of statin and placebo on the development of sepsis and organ dysfunction in ICU patients.
Public title
Effaect of Statin on Sepsis and organ dysfunction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Patient with sepsis in the context of pneumonia and urinary tract infections.
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into Statin and placebo groups by simple randomization method and by table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Research method is double blind clinical trial. Researcher (The outcome evaluator) and participants are not informed on receiving the statin or the placebo. Clinical caregivers take drugs that are named A and B to the patients. Data analyzer and Data Saftey and Monitoring Committee are aware of the fact that the participants have received Statin or placebo.
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
4
Description
Nervous system failure
Timepoint
daily
Method of measurement
Based on Glasgow Coma Scale
5
Description
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.
6
Description
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.
7
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group receive Atorvastatin 40 mg oral tablet, produced by the Abidi Company, daily for one month.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive B-complex vitamin oral tablet, produced by the Daroupakhsh Company daily for one month.