Quality of Life, the Incidence of Whole Complications Resultant From Decompensated Liver
Conditions
Keywords
Atorvastatin, Cirrhosis-related complications, Hepato-renal syndrome, oxidative stress.
Brief summary
The study aims to evaluate the impact of statin on hepatic decompensation.
Detailed description
Cirrhosis is the late stage of liver damage and possess two phases:. The shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative Impact on quality of life (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers
Interventions
DRUGAtorvastatin 20mg
active arm
DRUGPlacebo
placebo arm
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Trial participants, investigators, care providers and outcome assessors were blinded to treatment allocation. Atorvastatin and placebo tablet were pre-filled in capsule and put into nontransparent sealed bottle to be identical in appearance. Unique randomization codes were set for each participant to avoid inadvertent loss of blinding for all participants if one is unblinded. Data analysis and manuscript writing were performed after unblinding when data had been cleaned for primary and secondary endpoints and adverse events (AEs).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Admissibility measures were age ranged from 18 to 75, with a medical diagnosis of decompensated liver cirrhosis built on standard clinical symptoms, laboratory tests, imaging appearances and/or liver biopsy. Decompensation of the disease was labeled by to the lowest degree having one episode of severe complications, including ascites, SBP, jaundice, EGVB and HE.8 All participants were ready to be enrolled and had signed up the informed consent. The foremost
Exclusion criteria
involved the following: (1) life-deadly leukocytopenia (WBCs \< 1 × 109/l); (2) Pregnant women or lactating mother; (3) patients diagnosed to have primary or secondary liver cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| impact on decompensation | 6 months | change in recurrence of cirrhosis related complications |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORkhadija glal
assistant lecturer
Outcome results
None listed